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Devinder Pal obtained a Master Degree in Pharmacy from the prestigious Banaras ...... Forensic Science, Amity Institute of Forensic Sciences (AIFS), Amity ...

82nd OMICS Group Conference

2nd International Conference and Exhibition on

Pharmaceutical Regulatory Affairs November 23-24, 2012 Hyderabad International Convention Centre, India

Accepted Abstracts

Page 153

Pharmaceut Reg Affairs 2012, 1:4 http://dx.doi.org/10.4172/2167-7689.S1.008

2nd International Conference and Exhibition on

Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

Pharmacy regulation, a tool to ensure rational use of drugs, case of East Africa Afadhali Diallo

National University of Rwanda, Africa

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harmacy regulation is the primary activity to ensure a smooth running of pharmaceutical services. Duties of the pharmacists in regulatory affairs field are various due to the large field of operation, we can say communication with the partners helping them to understand local regulatory environment, preparation of the local files and documents to be ready for submission to the health authority in order to ensure that all partner’s documents remains highly confidential. It comprises drug importation and registration authorities, pharmacovigilance, inspection and supervision. At International Pharmaceutical Students’ Federation (IPSF), we equip participants with different skills such as time management, organizational skills and group working in order to find the best solutions in pharmacy regulation. A pharmacist as a life-long learner, good communicator, manager, leader and decision maker as stated in the seven-star pharmacist, the pharmacy regulation is assured. A number of African countries are home to illegal medicines’ trade and irrational use of drugs, they are sold as other else product while they should be protected in order to ensure proper use to enhance appropriate therapy. East Africa undertook strategies to regulate medicines flow. Global merged thoughts of health scientists and governments’ input are important to ensure a safe running of drug products in legal way of operation. Pharmacy regulation found its role in setting rules to enhance proper running of medicines in the country.

Biography Mr. Afadhali Diallo, pharmacy intern at Rubavu district hospital is the President of Africa Pharmacy students at International Pharmaceutical Students’ Federation (IPSF). He has represented his country in Kenya and Tanzania to their international pharmacy conferences also as Youth Ambassador at Project SAVE. He has organized the 2012 Central African Regional Symposium on drug abuse eradication. He participated in the first IPSF African Leaders In Training (LIT) and the first African Pharmaceutical Symposium in Algiers. He was elected the 2012-2013 Chairperson of IPSF African Regional Office for pharmacy students and recent graduates in July 2012. [email protected]

Development of new anticancer agents Ahmed Kamal

Indian Institute of Chemical Technology, India

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ancer continues to be a major health concern and a number of deaths are caused by cancer that is second only to cardiovascular diseases. The development of compounds that target genes involved in cancer pathogenesis is a potential area of cancer drug discovery. A number of anticancer drugs employed clinically exert their effect by inhibiting nucleic acid (DNA or RNA) or protein synthesis. It is evident that DNA is an important cellular target for many anticancer agents. Pyrrolo[2,1-c][1,4]benzodiazepines (PBDs) are naturally occurring compounds isolated from various Streptomyces species. The PBDs exert their biological activity through covalent binding within the minor groove of DNA. Several PBD conjugates have been synthesized to investigate the detailed biological aspects relating to the mechanism of action. Some of the potent molecules like PBD-quinazolinones and PBD-diaryloxadiazoles have been evaluated for their in vivo efficacy studies. These studies suggest that such PBD conjugates have promising anticancer activity. Some of the PBD conjugates act as activators of p53 and suppressors of NF-κB and thereby they could be considered as promising anticancer agents with improved potential for the suppression of tumours. To improve the selectivity as well as stability, some new β-galactoside prodrugs of PBDs have been synthesized and evaluated for their potential use in selective therapy of solid tumors by ADEPT and PMT protocols. Another important property of these molecules is their enhanced water solubility and stability, which are essential for a molecule to be an effective drug.

Biography Ahmed Kamal graduated from Osmania University, Hyderabad (India) and did his Ph.D. research in the area of Medicinal Chemistry. He later joined as a Scientist at the Indian Institute of Chemical Technology (IICT), Hyderabad. For the last 25 years, he has pursued his research career at IICT, Hyderabad and is presently working as an Outstanding Scientist. He also holds an additional charge of Project Director of NIPER, Hyderabad. He has over 290 publications, 12 review papers and 7 book chapters and has filed over 75 patents. He is serving as an editorial advisory board member for the journals of repute. [email protected]

Pharmaceut Reg Affairs 2012 ISSN: 2167-7689, PROA an open access journal

Pharma-2012

November 23-24, 2012

Volume 1 Issue 4 Page 154

Pharmaceut Reg Affairs 2012, 1:4 http://dx.doi.org/10.4172/2167-7689.S1.008

2nd International Conference and Exhibition on

Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

Development of new anticancer agents Ahmed Kamal

Indian Institute of Chemical Technology, India

C

ancer continues to be a major health concern and a number of deaths are caused by cancer that is second only to cardiovascular diseases. The development of compounds that target genes involved in cancer pathogenesis is a potential area of cancer drug discovery. A number of anticancer drugs employed clinically exert their effect by inhibiting nucleic acid (DNA or RNA) or protein synthesis. It is evident that DNA is an important cellular target for many anticancer agents. Pyrrolo[2,1-c][1,4]benzodiazepines (PBDs) are naturally occurring compounds isolated from various Streptomyces species. The PBDs exert their biological activity through covalent binding within the minor groove of DNA. Several PBD conjugates have been synthesized to investigate the detailed biological aspects relating to the mechanism of action. Some of the potent molecules like PBD-quinazolinones and PBD-diaryloxadiazoles have been evaluated for their in vivo efficacy studies. These studies suggest that such PBD conjugates have promising anticancer activity. Some of the PBD conjugates act as activators of p53 and suppressors of NF-κB and thereby they could be considered as promising anticancer agents with improved potential for the suppression of tumours. To improve the selectivity as well as stability, some new β-galactoside prodrugs of PBDs have been synthesized and evaluated for their potential use in selective therapy of solid tumors by ADEPT and PMT protocols. Another important property of these molecules is their enhanced water solubility and stability, which are essential for a molecule to be an effective drug.

Biography Ahmed Kamal graduated from Osmania University, Hyderabad (India) and did his Ph.D. research in the area of Medicinal Chemistry. He later joined as a Scientist at the Indian Institute of Chemical Technology (IICT), Hyderabad. For the last 25 years, he has pursued his research career at IICT, Hyderabad and is presently working as an Outstanding Scientist. He also holds an additional charge of Project Director of NIPER, Hyderabad. He has over 290 publications, 12 review papers and 7 book chapters and has filed over 75 patents. He is serving as an editorial advisory board member for the journals of repute. [email protected]

Tanshinone IIA could inhibit human hepatocellular carcinoma Hep-G2 cells through inducing ER stress in vitro Chin-Cheng Su

Changhua Christian Hospital, Taiwan

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anshinone IIA (Tan-IIA) is one of the diterpene quinone in Salviae miltiorrhizae Radix. Tan-IIA could inhibit many human cancer cells in vitro and in vivo through different molecular mechanisms. But the molecular mechanisms for Tan-IIA to inhibit hepatocellular carcinoma (H.C.C) were not well evaluated. In the present study, the cytotoxicity of Tan-IIA in H.C.C Hep-G2 cells was measured by M.T.T assay. The ER stress related protein expressions were evaluated by western blotter. For in vivo study, the Hep-G2 cells were implanted directly into SCID mice and then mice with Hep-G2 cells xerograft tumours were treated with Tan-IIA (I.P) every other day for 4 weeks. These mice were sacrificed with CO2 inhalation. The xerograft tumours were dissected and extracted the total protein for western blot. These results showed that Tan-IIA could inhibit H.C.C Hep-G2 cells with time and dose dependent in vitro. Tan-IIA could inhibit the growth of Hep-G2 cells xenograft tumor when compared with the control group. The ER stress related protein expressions ATF6, Caspase 12 and CHOP were up regulated when compared with the control group. These finding indicate that Tan-IIA could inhibit Hep-G2 through inducing ER stress in vitro.

Biography Chin Cheng Su has completed his Ph.D at the age of 42 years from Graduate Institute of Chinese Medical Science (2003-2006) from China Medical University, Taiwan. He is the director of tumor research center of integrative medicine and Co-Chair of the Comprehensive Breast cancer center and the Department of Surgery, Changhua Christian Hospital. He has published more than 36 papers in reputed journals and serving as a reviewer of reputed journals. [email protected]

Pharmaceut Reg Affairs 2012 ISSN: 2167-7689, PROA an open access journal

Pharma-2012

November 23-24, 2012

Volume 1 Issue 4 Page 155

Pharmaceut Reg Affairs 2012, 1:4 http://dx.doi.org/10.4172/2167-7689.S1.008

2nd International Conference and Exhibition on

Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

Luminescent quantum dots and upconversion nanocrystals: Synthesis and biomedical applications Amiya Priyam

Birla Institute of Technology, India

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mongst various types of luminescent nanomaterials, the two that have attracted attention worldwide are: 1. Semiconductor nanocrystals or quantum dots (QDs) and 2. Lanthanide based upconversion nanocrystals (UCNs). In semiconductor nanoparticles, unique optical properties such as size dependent luminescence arise due to spatial confinement of the charge carriers. In this talk, I would discuss the aqueous routes to obtain biocompatible, highly monodisperse and luminescent nanocrystals. In the synthetic methodology developed by us, the nanoparticles were capped with amino acids, thiols and dendrimers which impart stability, functionality and determine the solubility of these particles. The temporal evolution of these surface-functionalized nanocrystals has been thoroughly studied and key parameters affecting the luminescence efficiency and size distribution has been identified. Subsequently, the interaction of bio-functionalized nanoparticles with some biomolecules such as enzymes and bio-oxidants was investigated and new protocols for nanoparticle-based biosensors have been developed. These QDs exhibit very good optical properties and did overcome several limitations of the organic dyes that were conventionally used for biomedical applications. However, ‘blinking’ effects, tissue auto-fluorescence and cytotoxicity concerns limit their use in bio-imaging. The exciting UV/Vis light cannot penetrate tissues beyond 1 cm and therefore these materials are not suitable for deep tissue imaging. Upconversion luminescent nanomaterials (UCN) circumvent all these problems involved in bioimaging. They can be excited by near-IR (NIR) light where biological components do not absorb and the upconverted multicolor fluorescence can be observed with zero background and without causing photodamage to the cells. The second part of my talk would focus on such nanomaterials, specifically, Yb, Er co-doped NaYF4 nanocrystals which show unique property of NIR-to-vis photon upconversion. The synthesis of these nanocrystals and their use in fluorescence imaging of canerous cells would be discussed.

Biography Amiya Priyam (http://www.researcherid.com/rid/B-4164-2010) obtained his B.Sc. and M.Sc. degree in chemistry from University of Delhi, India. He completed his PhD from Jadavpur University in 2008. Subsequently, he worked as post-doctoral research fellow at Florida State University, USA and National University of Singapore. Currently, he is assistant professor in the department of applied chemistry at Birla Institute of Technology, Mesra, India. He is a life member of CRSI (Chemical Research Society of India) and MRSI (Materials Research Society of India). He also serves as reviewer for prestigious RSC journals. [email protected]

Pharmaceut Reg Affairs 2012 ISSN: 2167-7689, PROA an open access journal

Pharma-2012

November 23-24, 2012

Volume 1 Issue 4 Page 156

Pharmaceut Reg Affairs 2012, 1:4 http://dx.doi.org/10.4172/2167-7689.S1.008

2nd International Conference and Exhibition on

Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

Regulatory affairs for healthcare products Amudha Krishnamurthy

Life Sciences Quality and Regulatory Consultant, India

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egulatory Affairs has always been considered as a Drug registration department in Indian Pharmaceutical industry. When Drug Registration and Marketing approvals are essential day to day activities of a regulatory professional, there is lot more aspects bound to it beyond product registration. In a true scenario, Regulatory Affairs is a horizontal that cut across the Pharmaceutical Value chain right from Drug discovery, Drug Development, Manufacturing, Sales and Marketing and Post Marketing. In all of these phases there are number of compliance parameters to be met in order to pass the stringent regulatory scrutiny. Regulatory Compliance plays an integral role in Regulatory Affairs. It is a common belief that, when the product complies with its specification then quality is achieved. Testing the final product cannot assure the quality unless and otherwise it is built into the product itself. The concept of Quality by Design (QbD) helps in building the right product with a thorough understanding of the product and process by which it is developed. QbD applies equally to the software used in the Pharmaceutical Industry. Understanding and interpreting these regulations has always been a challenge in Pharma because Regulations like US FDA or UKMHRA would only provide the guidance document on its interested topics, the how aspect is left to the Pharmaceutical Company. Complying with these regulations is purely based on a company’s internal policies and Procedures. Despite these regulations exist for so many years now, even today there are so many non- conformances and FDA 483s. What is the challenge? Why compliance is always considered as a painful exercise? What role does a Regulatory Affairs professional play in this entire process? Wait and watch my session for the answers.

Biography Amudha Krishnamoorthy is a Life Sciences Quality and Regulatory Consultant having 15 years of Experience. She has served in Departments like Manufacturing, Quality Assurance and Regulatory Affairs in her Pharmaceutical Industry career and currently working as a Regulatory Consultant in IT Company. Her expertise includes GxP Compliance, Software Compliance and Regulatory Submissions. She is also a certified mentor for Life Sciences imparting domain knowledge to the IT folks. [email protected]

A country perspective in exploring the links between hospital pharmacies and pharmaceutical industry: A case study application Ana Margarida Santos Bravo1 and José Crespo de Carvalho2 Lisbon University Institute, Portugal

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he pharmaceutical industry is one of the firms where the search for quality is very close to compliance. Yet a major paradigm change is occurring in this industry and an increase of returns and recalls has been seen. Hence, in this paper the authors combine the findings of previous literature reviews with a case study approach. Findings from previous literature reviews emerged from the links explored between pharmaceutical drugs quality, reverse logistics and sustainability. With the application of a case study on a global manufacturing corporation in the area of generic drug products one more step is introduced: understanding the type of returns companies receive, in particular from hospital pharmacies. The role of hospital pharmaceutical returns as a potential major contributor in resolving the noncompliance challenges will be compared and contrasted from a country perspective. With this approach authors are creating a link between two different parties: the application of a quality by design (QbD) risk management approach with the reduction of variability and risk of noncompliance.

Biography Ana Margarida Santos Bravo is a Ph.D candidate at the age of 33 years from ISCTE, Lisbon University Institute, in Lisbon Portugal. She is a Researcher in Pharmaceutical Supply Chains. In addition, she is responsible for the Regulatory Affairs and Technology Transfer of injectable drug products to the US market in a global Pharmaceutical Organization. She has published several papers in reputed conferences and journals. [email protected]

Pharmaceut Reg Affairs 2012 ISSN: 2167-7689, PROA an open access journal

Pharma-2012

November 23-24, 2012

Volume 1 Issue 4 Page 157

Pharmaceut Reg Affairs 2012, 1:4 http://dx.doi.org/10.4172/2167-7689.S1.008

2nd International Conference and Exhibition on

Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

European regulatory framework for drug approval through the centralized system Andrea Laslop

Austrian Agency for Health and Food Safety, Austria

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he European drug regulatory system offers a number of different ways to approve medicinal products for human use. Besides national registration pathways and authorizationin several EU member states via the Decentralized Procedure there is growing use of the Centralized Procedure for approval in all member states. The focus of this overview aims at explaining the main features of the centralized authorization process in Europe. At the heart of the centralized system the European Medicines Agency (EMA) coordinates all applications from Sponsors. Delegates/experts from member states and local staff of the EMA contribute to a multitude of scientific committees and working groups. Regulatory requirements and support during product development are given by various guidelines and scientific advice. The latter is provided to Applicants by the Scientific Advice Working Party. For development of a new medicinal product or a new indication in most instances a paediatric investigation plan needs to be approved by the Paediatric Committee. Orphan designations, qualifying a product as orphan, are assessed by the Committee for Orphan Medicinal Products. The regulatory decision making process for concluding on the benefit/risk balance of a medicinal product is one of the main tasks of the Committee for Medicinal Products for Human Use. This scientific body issues an opinion to the European Commission and thereby either recommends or rejects the marketing authorization. A number of drugs, such as biotechnology compounds, orphan drugs and products for several therapeutic classes have to be evaluated via the centralized system on a mandatory basis, whereas for others an optional scope exists. The post-approval measures will now significantly change with the implementation of the new Pharmacovigilance legislation and introduction of a new committee, the PharmacovigilanceRisk Assessment Committee, with a mandate to regulate the life-cycle of products after approval. An intimate cooperation will ensure that drugs brought to the European market are efficacious and safe and continue to have a positive ratio of benefit and risk.

Biography Andrea Laslop joined the Austrian Agency for Health and Food Safetyin 2006. She heads the Scientific Office, which constitutes the link to the European Medicines Agency (EMA), focussing on centralized procedures during drug development, marketing authorization applications and lifecycle management. Andrea Laslop is a member of the Scientific Advice Working Party of the EMA since 2003and Austrian delegate in the Committee for Medicinal Products for Human Use since 2007. Previouslyshe worked as professor of pharmacology and toxicology at the Medical University of Innsbruck, Austria. She studied medicine there and then specialized as pharmacologist. Her professional career included research fellowships at NIMH in Bethesda, Albert Einstein College of Medicine in New York and Clinical Research Institute of Montreal. Since November 2007 she served as president of the Austrian Pharmacological Society and from November 2011 as vice president. [email protected]

GLPs in pharmaceutical industry and the differentiation factor B Anil Kumar Singh

Vegesna Laboratories Private Limited, India

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he objective of the presentation is to bring out the differences between various GLP guidance like Schedule L1, Drugs and Cosmetics Act, 1940, Government of India and the WHO Good Practices for Pharmaceutical Quality Control Laboratories and so on.

Biography B.Anil Kumar Singh has completed his M.Sc (Organic Chemistry) from Andhra University. He is also lead auditor through experience in the auditing and through certification in ISO 9001:2008 from TUV SUD. He is the General Manager of Quality Operations (QA/QC/RA), who has an experience in premier pharmaceutical manufacturing organizations Like Dr.Reddy’s,Fresenius Kabi Oncology Limited, Aanjaneya Lifecare Limited involved in APIs/HPAIs and Formulations. Presently associated with Vegesna Laboratories Pvt. Limited. [email protected]

Pharmaceut Reg Affairs 2012 ISSN: 2167-7689, PROA an open access journal

Pharma-2012

November 23-24, 2012

Volume 1 Issue 4 Page 158

Pharmaceut Reg Affairs 2012, 1:4 http://dx.doi.org/10.4172/2167-7689.S1.008

2nd International Conference and Exhibition on

Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

Pre-analytics- a challenge less heeded Aparna Jha Ahuja SRL Diagnostics, India

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re-analytical phase is the most vulnerable part of the total testing process in any clinical trial. The pre-analytical variables include specimen collection, handling, processing, physiological influences and/or interference factors. Pre-analytics is considered to be among the greatest challenges to the laboratory fraternity. However, pre-analytical activities, management of unsuitable specimens and reporting policies are not fully standardized worldwide. There are no internationally accepted guidelines and recommendations as well as related quality measures available for pre-analytical phase. There is large heterogeneity in the criteria for sample rejection, the different strategies by which unacceptable samples are managed, processed and test results reported worldwide. Good practices and compliance with the new strategies for error prevention can lead to a substantial reduction in pre-analytical errors.

Biography Aparna Jha Ahuja is Lab Director of Clinical Reference Lab, SRL Diagnostics, Gurgaon and also heads Clinical Trials Lab, Biochemistry & specialized Chemistry. She is a member of core SRL Leadership Teams and has more than 2 decades experience. She completed MBBS (with distinction), MD (Medical Biochemistry) and PG certificate in hospital management from prestigious Institutes in New Delhi. She is an auditor with NABL (India) and CAP (US). She has publications in reputed international journals and is Life Member of scientific societies like Indian Medical Association, DMA, AMBI & ACBI. She has been invited as panelist/chairperson/speaker by media and in several National/International fora like Arab Health Congress, Indo-US summit and WHO summit. She has organized several CMEs/training sessions/workshops, the recent one being the workshop co-organized with CAP. [email protected]

Biological evaluation of anti-diabetic drug encapsulated in ethosomes systems for enhanced transdermal delivery Arivind Sharma and Arora Navneet Bhulli Chitkara College of pharmacy, India

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limepiride is one of the third generation sulfonylureas used for treatment of type 2 diabetes. Poor aqueous solubility and slow dissolution rate of the drug lead to irreproducible clinical response or therapeutic failure in some cases due to subtherapeutic plasma drug levels. Consequently, the rationale of this study was to improve the biological performance of this drug through enhancing its solubility and dissolution rate. This research is focused the work carried out in vitro, in vivo in both animal and humans with various ethosomal and transfersomal formulations with particular emphasis on ethosomes. Ethosomes represent a lipid vesicular carrier system embodying ethanol in relatively high concentration and are very efficient in delivering drugs into and across the skin. Unlike classic vesicular carrier that are known to mainly deliver drugs to outer layers of skin, ethosomes penetrate through the stratum corneum and deliver drugs to the deeper layers of skin.

Biography I, Arvind Sharma have completed his M.pharmacy from Punjabi university Patiala Punjab India and persuading PhD from chitkara university Punjab. I am working as Assistant professor (pharmaceutics) in Chitkara College of pharmacy for last 2.5 years and total 4 years of research experience . I have published more than 23 papers in reputed journals and attended more than 20 National and 5 international conferences. I am full member of http://members.nanosociety.us/ Arvind. I have supervised 10 students for their research project. My core area of research drug delivery system, control and susutained release. [email protected]

Pharmaceut Reg Affairs 2012 ISSN: 2167-7689, PROA an open access journal

Pharma-2012

November 23-24, 2012

Volume 1 Issue 4 Page 159

Pharmaceut Reg Affairs 2012, 1:4 http://dx.doi.org/10.4172/2167-7689.S1.008

2nd International Conference and Exhibition on

Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

Patents in Indian pharmaceutical industry: Legal and ethical issues B. S. Kuchekar

MAEER’s Maharashtra Institute of Pharmacy, India

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n the post-independence era, the Indian pharma market was completely dominated by multinational companies (MNCs) and most of the medicines were imported in India. The cost of medicines in India was among the highest in the world. In 1970, Indian Patents Act 1970 was passed which allowed only process patents for new molecules and chemical entities (NCEs). This law opened gates for reverse engineering of medicines thus brought down price of medicines in India to affordable level. However the post TRIPS (i.e. post 1995) era has seen the paradigm shift from generic product development to innovative R&D and basic R&D. The legal issues mainly focus on the effective enforcement of patent laws in India. If we look at the history, the Indian pharma companies have flourished due to weaker Indian patent law. However as a legal binding, Indian government being a signatory to TRIPs implemented product patent system in India. The developed nations backed by MNCs are putting pressure of Indian Government to implement strict patents laws in view of TRIPs agreement. The ethical issues highlight the access and affordability of essential medicines to Indian citizens. It is well known fact that the strict patents reduce the availability and affordability of new essential drugs in developing countries, and thereby have a negative impact on the health of poor patients. There are few legal tools available in the TRIPs such as compulsory licensing which needs to be fully exploited by Indian government.

Biography B. S. Kuchekar has completed his Ph.D. degree in Pharmaceutical Chemistry in 2002. He has 33 years experience in academics. He has published 135 research papers and 29 reviews. 4 books and 2 patents are to his credit. He has guided 45 postgraduate and 8 Ph.D. scholars. He did LL.B. from New Law College Pune, India and P. G. Diploma in Patents law from NALSAR University, Hyderabad. Currently he is working as a Principal and Professor at Maharashtra Institute of Pharmacy, MIT campus, Pune, India. [email protected]

New drug application under section 505(b) (2): Preferred USFDA regulatory approval pathway Balaram Gajra

Charotar University of Science and Technology, India

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nited States Food and Drug Administration (USFDA) has three sections of New Drug Application (NDA) approval pathway: Section 505(b) (1), 505(b) (2) and 505(j). 505(j) is known as Abbreviated New Drug Application (ANDA). According to section 505(b) (1) or full NDA, the application must contain full reports of investigations of safety and effectiveness. 505(j) or ANDA is for a proposed drug that is identical to a reference listed drug and must demonstrates its bioequivalence and the product is called as generic drug product. The 505(b) (2) is intermediate of full NDA and the ANDA, it proposes a limited change to a previously approved product and demonstrates the required safety and efficacy of the change. The changes to approved drugs which would be appropriate to submit as 505(b) (2) applications are changes in dosage form, strength, formulation, dosing regimen or route of administration; a new combination product, including substitution of an active ingredient; modified active ingredient (i.e. salt, chelate, ester, complex, etc.); new indications for previously approved drugs; over-the-counter switch of an approved prescription drug. In fiscal year 2006, approximately 20% of new drugs were approved through the 505(b) (2) process. In 2007, the number was about 43%. In 2008, more than half of the new drugs approved in the United States were based on the 505(b) (2) process. This figure has been increased to 65 % in 2009 and it is expected that by the end of 2012 it will raise to 90 %. The reasons behind increase in the number of the applications under 505(b) (2) are its advantages over the 505(b) (1) such as: eliminates the duplicative costly and time consuming clinical studies, applicant may qualify for 3-5 years of market exclusivity, less cost, less risk, less time consuming than the full NDA.

Biography Balaram Gajra has completed Masters from Banaras Hindu University, Varanasi, India and Ph.D from Faculty of Pharmaceutical Sciences, Kachchh Universuty, Bhuj, India. He is Associate Professor at Ramanabhai Patel College of Pharmacy, Charotar University of Science and Technology, India. He has published more than 12 papers in reputed journals and presented more than 30 papers in national and international conferences. Currently he is guiding 5 Masters projects and 2 doctorate projects. [email protected]

Pharmaceut Reg Affairs 2012 ISSN: 2167-7689, PROA an open access journal

Pharma-2012

November 23-24, 2012

Volume 1 Issue 4 Page 160

Pharmaceut Reg Affairs 2012, 1:4 http://dx.doi.org/10.4172/2167-7689.S1.008

2nd International Conference and Exhibition on

Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

Crystallization in the pharmaceutical industry Balbir Negi

SHAH TC Overseas Pvt. Ltd, India

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rystallization has the vital role in the pharmaceutical industry as it is started from intermediates separationprocess and the final manufacture step as active pharmaceutical ingredients. Crystallization is a key component of almost all processes in the manufacturing of pharmaceuticals. Whether for purification of intermediates, formation of the product, or prevention of crystallization in amorphous products, crystallization is essential in both processing & development. Crystallization can be natural or artificial process of formation of solid crystal sprecipitating from a solution melts or more rarely deposited directly from a gas. Crystallization is also a chemical solid–liquid separation technique, in which mass transfer of a solute from the liquid solution to a pure solid crystalline phase occurs. If we take an example of third generation, semi synthetic, broad-spectrum cephalosporin Ceftriaxone sodium, which belongs to β-lactam antibiotics. This is most in demand able anti-infectious production India and abroad. The continuous methodical studies and development of R& D have been performed to resolve the problems faced in the industry manufacture of ceftriaxone sodium, for example the low yield of batches, less commercial batches and no uniform of the quality so on. With the help of R & D the problem is studied and continuous lab batches taken and data evaluated. A new process of dilution crystallization has been successfully used for industry manufacture of ceftriaxone sodium, and the product quality, yield and size were enhanced much more than that of the old technology. In past the India has done more studies and research on the crystal formation of ceftriaxone sodium. By evaluating the type of equipment for crystallization, solvent quality, maintaining temperature, recovering solvent, time for reflux, effects of seeds, stirring RPM control, purification and concentration of mother liquor the crystallization process is developed. After intensive work on the crystallization of ceftriaxone sodium has been determined, and the product quality, yield and size are improved.

Biography Balbir Singh Negi has completed his M.sc Chemistry in 1990 at the age of 23 years from Hemwati Nandan Bahuguna Garhwal Universityand M.B.A in Project Management from Sikkim Manipal University completedin 2011. In 1996 received D.sc Honorary degree from the Open International University of Complementary Medicine, Srilanka. He is the GM Regulatory Affairs in Shah Trading Corporation Overseas Private Limited, Delhi, INDIA, an APIs trading company having office in India and China. Coordinating the licensing authority Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India and Central Drug Testing laboratory Mumbai India. He has total 22 yrs experiencefrom reputed MNC Ranbaxy labs Ltd, Venus Remedies Ltd and CliniRx Research P Ltd in field of APIs- Manufacturing, Quality Assurance, Regulatory Compliance, Formulation - Regulatory Compliance and CRO - Project Management. [email protected]

Pharmaceut Reg Affairs 2012 ISSN: 2167-7689, PROA an open access journal

Pharma-2012

November 23-24, 2012

Volume 1 Issue 4 Page 161

Pharmaceut Reg Affairs 2012, 1:4 http://dx.doi.org/10.4172/2167-7689.S1.008

2nd International Conference and Exhibition on

Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

Stereoselective syntheses of naturally occurring 20-epi cholanic acid derivatives and other bioactive compounds from 16 dehydropregnenolone acetate Bapurao B. Shingate

Dr. Babasaheb Ambedkar Marathwada University, India

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wide variety of diterpenes, sesquiterpenes and steroids have been reported to have modified isooctyl (cholesterol-type) side chains and the unit being attached to the polycyclic nucleus at C-17 with (R) or (S) stereochemistry at C-20. The introduction of the properly functionalized side chains onto tetracyclic steroidal starting materials has been the subject matter of several investigations. An important problem that arises in this approach is the stereoselective control of the C-20 stereochemistry. These efforts have been spurred by the biological significance of new natural products containing modified side chains and synthetic endeavors towards a variety of vitamin D metabolites, brassinosteroids, squalamine, OSW-1, ent-steroids and various marine steroids. We have reported the synthesis of C(20R) aldehydes by ionic hydrogenation of C-20, 22-ketene dithioacetal and C-20 tertiary alcohols with 100% stereoselectivity. In continuation of this and other work, we wish to report here the stereoselective synthesis and ionic hydrogenation of various steroidal C-20 tertiary alcohols to the corresponding steroid derivatives with natural and unnatural configuration at C-20. Elaboration of the synthesized intermediates to biologically active compounds will be discussed.

Biography Bapurao B. Shingate has obtained B.Sc and M.Sc. degrees from Dr. Babasaheb Ambedkar Marathwada University, Aurangabad (MS), India. He did his Ph.D degree in 2010 from University of Pune, Pune (MS) under the supervision of Dr. Braja G. Hazra at Division of Organic Chemistry, National Chemical Laboratory (CSIR), Pune. His Ph.D work focused on the stereoselective syntheses of steroidal unnatural C(20R) aldehydes by ionic hydrogenation and their elaboration to naturally occurring 20-epi cholanic acid derivatives. His current research interests include asymmetric synthesis, total synthesis of natural products, multi-component reactions, heterocyclic synthesis and green chemistry. He has published about 50 research articles in the journals of international repute and written 1 chapter of a book. [email protected]

Regulatory status of biosimilar medicinal products in Europe and USA Begoña Calvo

University of the Basque Country, Spain

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hen a biopharmaceutical product patent expires, other manufacturers can produce copies of the original drug. These products, called biosimilars are similar but not identical to the innovator drug due to the protein nature complexity . Biosimilars, unlike chemical synthesis generics, can only obtain a marketing approval at European level through a centralized procedure overviewed by the European Medicines Agency (EMA). In order to test the efficacy, safety and quality of biosimilars, the EMA has established several mandatory guidelines that will be discussed. The current situation at USA will also be analized as well as the harmonization perspectives at global level.

Biography Begoña Calvo at present is Professor at the Department of Pharmaceutical Technology, University of the Basque Country (Spain). She earned her Ph.D. from University of Salamanca (Spain) and Post-doctorate from Mario Negri Institute for Pharmacological Research (Italy). She has published and presented more than eighty original research papers, articles and abstracts in peer reviewed journals and conferences. Her main scientific areas of research are Experimental and Clinical Pharmacokinetics as well as the Regulatory basis of biopharmaceuticals. He serves as reviewer for more than 20 scientific international journals. [email protected]

Pharmaceut Reg Affairs 2012 ISSN: 2167-7689, PROA an open access journal

Pharma-2012

November 23-24, 2012

Volume 1 Issue 4 Page 162

Pharmaceut Reg Affairs 2012, 1:4 http://dx.doi.org/10.4172/2167-7689.S1.008

2nd International Conference and Exhibition on

Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

Formulation and evaluation of fast disintegrating sublingual tablets of Rizatriptan Bharathi Dhasan

Arulmigu Kalasalingam College of Pharmacy, India

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n our study, Rizatriptan sublingual tablets 100mg were prepared by using super disintegrants crospovidone, croscamellose sodium and L-HPC at different concentrations. The values of blend parameters evaluated within the prescribed limits and shows good free flow property. Angle of repose of the powder mixture prepared for tablet preparation ranged from 290.91-320.31 and was within the Pharmacopeial limits. The compressibility index was calculated for the powder mixture and was within the range of 10.45-14.21%. The hausner’s ratio was calculated and the range of the ratio is 1.11-1.15. If the ratio value is closer to one then the powder mixture has good flow property. The tablets were prepared by direct compression method using single rotary tablet punching machine with 7mm punch. Drug content in the tablet was determined by dissolving it in the buffer and the drug content is determined by serial dilution. The percentage drug content of all formulations was found to be between the ranges of 98.34-100.27%. The hardness of the tablet was calculated by using Monte’s hardness apparatus and the values were within the range of 2.4-3.1 kg/cm2. The thickness of the tablet was calculated by using Vernier calipers and the thickness of the tablet was found to be 2.67-2.94 mm. In all the formulations the friability values are less than 1% and it is within the limits. Wetting time of the tablets lies between 7-16secs. Among all the formulations, F-10 showed less wetting time of 7.2secs as it in mixed with the super disintegrants crospovidone and croscamellose sodium. Water absorption ratio of the tablets was found to be in the range of 27.18-42.18%. Disintegration time of the sublingual tablets was found to be between 11- 18secs which should be as low as possible to show quick onset of action. Increasing the amount of super disintegrants caused the decrease in the disintegration time. The formulation F3 was kept for stability studies in stability chamber for 250C/60%RH and 400C/75%RH for 3 months. No significant changes were seen in the formulation. There was a slight increase in hardness, disintegration time and slight decrease in percentage drug release. After subjecting the tablets to in vitro dissolution studies for 10 mins in pH 6.8 phosphate buffer in USP model I apparatus at 50 rpm, formulations F1 showed 81.96%, F2 showed 90.46%, F3 showed 98.79%, F4 showed 78.34%, F5 showed 87.38%, F6 showed 95.9%, F7 showed 77.38%, F8 showed 85.87%, F9 showed 92.54% and F10 showed 99.34% drug release. From the above percentage of drug release values, F1, F4 & F7 were less than 85% after 10mins. F2, F5, F8 & F9 batches showed drug release ranging from 85 to 95% whereas F3, F6 & F10 showed excellent drug release of more than 95%. Among these three the optimum formulation is F10 but F3 was selected as a best formulation because of its best mouth feel. The mixing of super disintegrants with the drug alters the dissolution rate and plays important role in the drug release. Higher the concentration of super disintegrants increases the amount of drug release.

Biography BHARATHI DHASAN has completed M.Pharmacy from Birla Institute of Technology, Mesra, Ranchi and Ph.D from Tamil University Thanjavur. He has extensively worked on phytochemicals and natural products research in various industries for about 12 years. Currently he is heading the department of pharmaceutics at Arulmigu Kalasalingam College of Pharmacy, Tamilnadu, India. He has published more than 12 papers in reputed journals. [email protected]

Pharmaceut Reg Affairs 2012 ISSN: 2167-7689, PROA an open access journal

Pharma-2012

November 23-24, 2012

Volume 1 Issue 4 Page 163

Pharmaceut Reg Affairs 2012, 1:4 http://dx.doi.org/10.4172/2167-7689.S1.008

2nd International Conference and Exhibition on

Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

A philosophical and scientific approach to evaluate preventive & curative medicinal uses of herbal, natural products, food additives, neutraceuticals (ayurveda) and pharmaceuticals (allopath) D L Sharma

Omatek lab Pvt Ltd, India

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t is very important to evaluate classical and recent development of medicinal systems, their basic principal and truth behind their usage, this is an approach to take insight view on Pharmaceuticals and a most ancient systems of medicines in the world. Ayurvedic medicines are one of the most ancient systems of treatment in India & now spreading globally. India has a rich heritage of usage of Ayurvedic & Herbal medicines supported by neutraceuticals. Ayurveda and Herbal have just recently started rising on the horizon of alternative system of medicine. Ayurveda and Herbal were being practiced, used and now getting legal support all over the world. Current Global market of Herbal & Ayurvedic medicines is estimated to be more than US$ 100 billion, out of this E.U. accounts for about 40%, Japan 20%, USA 10%. The Asian countries together account for 30% of the global market It’s uses are more as food additives, preventive medicines and now curative specifically diseases related to elementary canal. Unani system is also similar to Ayurveda with some exeptions Allopath (Pharmaceuticals) and modern surgery supported by scientific evaluation, chemistry and clinical study has vast area of use for quick relief, globally 70% people use this system in case of cure disease. Homeopathy is a medicinal system their basic principal is based on natural body reaction, it is more body science then chemistry is best system for allergy.

Biography D L Sharma has completed his Ph.D in 2001, at the age of 45 years from Maulana Azad College of Technology (MACT) Bhopal MP. He was in Athletics and created record for MP, Indore & Ujjain university Athletics, also he was captain of these teams, Taken many training in R&D Instrumentation and QA/QC Systems in India and abroad, visited Singapore, Viena (Austria), Hongkong, China and USA. He has setup QA Systems and QC Lab in Lupin, orhid and zydus cadila, now set up his own lab and business, now he is the Managing director of Omatek lab Pvt ltd Indore India, a R&D Based pharma nutra mfg co since last 8 yrs, Prior to this co he was in Lupin R&D for 7 yrs, in Orchid Chemicals QA/QC for 9 yrs and Zydus cadila / other pharma companies for 8 yr total 32 yr experience in pharma / nutra industry. He has set up four reputed QC/R&D lab and worked as team leaders of up to 50 scientists, Presented hes speech / lectures in Anacon, PDH and infomedia conferences. [email protected]

Tanshinone IIA could inhibit human hepatocellular carcinoma Hep-G2 cells through inducing ER stress in vitro Chin-Cheng Su

Changhua Christian Hospital, Taiwan

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anshinone IIA (Tan-IIA) is one of the diterpene quinone in Salviae miltiorrhizae Radix. Tan-IIA could inhibit many human cancer cells in vitro and in vivo through different molecular mechanisms. But the molecular mechanisms for Tan-IIA to inhibit hepatocellular carcinoma (H.C.C) were not well evaluated. In the present study, the cytotoxicity of Tan-IIA in H.C.C Hep-G2 cells was measured by M.T.T assay. The ER stress related protein expressions were evaluated by western blotter. For in vivo study, the Hep-G2 cells were implanted directly into SCID mice and then mice with Hep-G2 cells xerograft tumours were treated with Tan-IIA (I.P) every other day for 4 weeks. These mice were sacrificed with CO2 inhalation. The xerograft tumours were dissected and extracted the total protein for western blot. These results showed that Tan-IIA could inhibit H.C.C Hep-G2 cells with time and dose dependent in vitro. Tan-IIA could inhibit the growth of Hep-G2 cells xenograft tumor when compared with the control group. The ER stress related protein expressions ATF6, Caspase 12 and CHOP were up regulated when compared with the control group. These finding indicate that Tan-IIA could inhibit Hep-G2 through inducing ER stress in vitro.

Biography Chin Cheng Su has completed his Ph.D at the age of 42 years from Graduate Institute of Chinese Medical Science (2003-2006) from China Medical University, Taiwan. He is the director of tumor research center of integrative medicine and Co-Chair of the Comprehensive Breast cancer center and the Department of Surgery, Changhua Christian Hospital. He has published more than 36 papers in reputed journals and serving as a reviewer of reputed journals. [email protected]

Pharmaceut Reg Affairs 2012 ISSN: 2167-7689, PROA an open access journal

Pharma-2012

November 23-24, 2012

Volume 1 Issue 4 Page 164

Pharmaceut Reg Affairs 2012, 1:4 http://dx.doi.org/10.4172/2167-7689.S1.008

2nd International Conference and Exhibition on

Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

Development of herbal formulations through traditional knowledge and scientific validation Dayanandan Mani

University of Lucknow, India

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yurveda (“The Science of Life”) has its emergence from Vedas (“The Source of Knowledge”) because of antiquity and similarity in contents. Rigveda (2000 B.C.) is the authentic source of knowledge about the use of the plants for food and drugs. Under Ausadhi-Sukta in Rigveda innumerable places of their origin and habitat have been described and they are used to make animal and man free from disease. In Atharvaveda (1500 B.C.), many more plants have been described to be used to cure disease. Use of plants in various disorders was based on prior observation on animals and later on their rationale-based use has been narrated in Charaka Samhita and Susruta Samhita (1000 B.C.). In fact, many of the concepts had their foundation laid down in the Vedic period (2000 B.C. – 1500 B.C.) and were also scientifically explained in original and classical compendia of Ayurveda. On the whole, the theory Panchamahabhutas is most important in Ayurveda. According to it all the substances of the universe (including human beings) are essentially composed of five basic elements - Panchamahabhutas (air, water, fire, earth and space). Substances are classified into two broad groups based on their use as dietary substances and drug substances. If they are in a balanced state, a person is known as healthy and their derangement (increase or decrease) causes disorders. Based on the various sign and symptoms in a body they are understood through the concept of Tridosha - Vata, Pitta and Kapha, which also have a panchabhautika base. To alleviate the disease, drug substances of plant, animal and mineral origin are used to correct the derangement and bring back normalcy. Rasayana therapy is specific to the Ayurvedic system of medicine. In fact the word “Rasa” has different meanings like "taste“, “essence", "flavor”, “juice”, or “emotion", but is not limited to any of these. In therapeutic process Rasa is concerned with the conservation, transformation, and revitalization of energy. It nourishes our body, boosts immunity and helps to keep the body and mind in best of health. Rasayana describes a herbal preparation that promotes a youthful state of physical and mental health and expands happiness. Rasayana herbs have high levels of both safety for daily use and effectiveness. They are given to small children as tonic, and are also taken by the middle-aged and elderly to increase longevity and vitality. Towards harnessing the traditional Indian medicine knowledge base for benefit of human mankind, CSIR-CIMAP has developed and scientifically validated some herbal formulations like CIMAP-Phal-Se, CIMAP-Paushak, CIMAP-Health Candy and IVT-15 (for rheumatoid arthritis related disorder) that are based on the concept of Rasayana.

Biography Dayanandan Mani has completed his MD Ayurveda in Kaya Chikitsa (Internal Medicine) in 2002 at the age of 31 years from the State Ayurvedic College and Hospital of the University of Lucknow. He joined CSIR-CIMAP, Lucknow as a Scientist Fellow in 2003 and continued on that position upto 2005 when he joined the same institute as a Scientist. Presently he is the Head of the Herbal Medicinal Products Department (HMPD) of CSIRCIMAP. He has published 20 papers and guided 12 (PhD/MD/MSc/MPharm) students. He is a life member of the Medicinal and Aromatic Plant Society of India (MAPSI). [email protected]

Pharmaceut Reg Affairs 2012 ISSN: 2167-7689, PROA an open access journal

Pharma-2012

November 23-24, 2012

Volume 1 Issue 4 Page 165

Pharmaceut Reg Affairs 2012, 1:4 http://dx.doi.org/10.4172/2167-7689.S1.008

2nd International Conference and Exhibition on

Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

Medication errors in pediatric population: Magnitude and interventions Deepa Arora

Lupin Limited, India

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edication errors are an important cause of iatrogenic morbidity and mortality. There is limited evidence to indicate that children may be more vulnerable to medication errors because of the need for a weight-based dosing approach and the increased sensitivity of children to relatively small dosing errors. Polypharmacy, the lack of effective communication between children and healthcare personnel as well as prescribing errors for example incomplete or illegible prescription, incorrect route or incorrect intravenous infusion are common errors. Off-label or unlicensed use in pediatric population also contribute to medication errors. As medication errors are preventable errors, these require special attention. Multifaceted interventions including all members of healthcare team, i.e. physician, nurses, pharmacists as well caretakers are required. Interventions to prevent medication errors include computerization of prescriptions, electronic medical records, voluntary and triggered reporting. As the incidence and type of medication errors vary widely with hospitals, local evaluation of the type, frequency and root cause of various medication errors as well as customization of corrective measures may be desirable. Magnitude of medication errors in pediatric population, their impact on society and interventions to reduce medication errors have been discussed in this presentation.

Biography Deepa Arora is a Physician having more than 15 years of experience in drug safety and clinical development in pharma industry and in academia. She has been in leadership and strategic roles in MNCs and Indian Pharma companies and successfully set up systems, developed teams and interacted with regulatory agencies in different regions including US, Europe, India and Australia. She has played an active role in developing awareness and skills of pharmacovigilance in the region by designing teaching modules for safety in medical institutions and training in pharmacovigilance workshops and courses. She is the author of the book “Pharmacovigilance- An Industry Perspective”. She is working with Lupin Limited as the Global Head- Drug Safety & Risk Management. [email protected]

Regulatory perspectives on drug dissolution testing Deepika Agarwal

Dr. Reddy’s Laboratories Ltd., India

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issolution is considered to be surrogate parameter for in vivo release of drug product and for the bioavailability of the active ingredient and finally for therapeutic efficacy. Dissolution testing is an official test used by pharmacopeias for evaluating drug release of solid and semisolid dosage forms. Dissolution testing is used as regulatory tool to review the lot-to-lot quality of a drug product (Quality control), developing IVIVC and to ensure continuing product quality and performance after certain changes, such as changes in the formulation, the manufacturing process, the site of manufacture, and the scale-up of the manufacturing process. For majority of regulatory body’s dissolution testing is critical to grant BCS based bio waiver and to check alcohol-induced dose-dumping of generic modified release oral drug products. Both US FDA and EMA emphasize on the need for an early identification of formulation and manufacturing factors that are important for setting satisfactory specification limits for the dissolution rate of an active substance from a dosage form. Thus dissolution test is expected to be an appropriate tool to detect deviations in those formulation factors that are defined to be critical in respect to drug absorption.

Biography Deepika Agarwal has done her PhD from Panjab University, Chandigarh in field of pharmaceutics and postdoctoral studies from Medical College of WI, USA. She is working in Dr Reddy’s Laboratories Pvt Ltd as Sr Manger. She has about 20 publications and presentations in reputed journals and conferences. [email protected]

Pharmaceut Reg Affairs 2012 ISSN: 2167-7689, PROA an open access journal

Pharma-2012

November 23-24, 2012

Volume 1 Issue 4 Page 166

Pharmaceut Reg Affairs 2012, 1:4 http://dx.doi.org/10.4172/2167-7689.S1.008

2nd International Conference and Exhibition on

Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

Global scenario of traditional herbal medicines – Impact on ayurveda Deepika Gunawant Max Ventures, India

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here has been an amazing increase in the use and demand of Traditional herbal medicines globally in the last couple of years. Worldwide it is recognized that there are different traditions within the herbal medicine and that individual practitioners utilize a range of treatment modalities within the scope of their practice .Traditional systems of medicine are very much a part of the health care system in their own country of origin . Ayurveda has existed as part of the health care system in India and over the years has developed facing major challenges to meet the growing concern on the safety and quality of the herbal medicines. It is clear that natural does not always equal safe which has eventually lead to each country having its own categorization ,strategy and regulations for Traditional Medicine and Complementary and Alternative Medicine. One regulation that fits all - does not exist and this has lead to a whole lot of challenges to face and to address. The first step has been initiated by WHO in 2006 with the setting up of the INTERNATIONAL REGULATORY CO-OPERATION FOR HERBAL MEDICINES (IRCH) which is a global network of regulatory authorities responsible for regulation of herbal medicines. Its mission being to protect and promote public health and safety through improved regulations for herbal medicines. The presentation will research into the existing global scenario on traditional and herbal medicines and status of Ayurveda in other countries.

Biography Deepika Gunawant , is an MD in Ayurveda from Kolkata University with a strong interest in mind-body medicine and developing clinical models in Integrative medicine ,education and wellness . She is presently - MEDICAL DIRECTOR at the MAX CENTRE FOR INTEGRATIVE MEDICINE,NEW DELHI . She also serves as an expert with National Accreditation Board for Certification Bodies (NABCB ) and was a former consultant with AYUSH – Department of Health. She has a rich and wide experience of over two decades ranging from clinical,research, teaching,marketing and regulatory both in India and abroad . She has been a Consultant with the MHRA (Medicines and Health Care Regulatory Agency ) and a member of the Herbal Medicines Regulatory Working Group formed by the Department of Health ,UK. She was the Chief Physician and Marketing Director with the Ayurvedic Hospital in London and was a faculty member with the Thames Valley University ,UK. She has lectured extensively and conducted Ayurveda and Wellness programmes in Europe. She is the co-author of the book entitled “Complete Illustrated guide to Ayurveda “ published by Element Books which is available in over 500 libraries worldwide. [email protected]

Pharmaceut Reg Affairs 2012 ISSN: 2167-7689, PROA an open access journal

Pharma-2012

November 23-24, 2012

Volume 1 Issue 4 Page 167

Pharmaceut Reg Affairs 2012, 1:4 http://dx.doi.org/10.4172/2167-7689.S1.008

2nd International Conference and Exhibition on

Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

Kaleidoscope of healthcare Devinder Pal

Catalyst Pharma Consulting, India

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aleidoscope of Healthcare will present different facets of a variety of elements of healthcare. The three drivers of this ever changing panorama: “Jugaad” – a bane and boon, “Big Pharma Big Troubles” and the “Healthcare on the Horizon”. Jugaad essentially means ‘frugal innovation’… any kind of creative thinking that maximizes the value of resources and outcome. Jugaad also has immense possibilities of getting misunderstood … get misdirected and misused to show impossible performances. It may work for a while but eventually, spells disaster. FDA is trying to make an example of companies that are trying to push the envelope. With the Emerging Markets (EM) becoming more important, the FDA oversight is also expected to change. Big pharma is facing big troubles. Over 70% of the NCEs don’t recover their cost of discovery. How are they attempting to overcome the most unusual challenges in their history? …“Amputating” themselves to “improve prognosis”? … The EM?. ‘FDA management’ is on the top of the list of the three Key Success Factors. Healthcare on the horizon points to a future totally divorced from where we stand today… entirely new paradigm? Several outstanding discoveries lab grown organs, spray- on-skin to heal without scarring… many more … The presentation will end with an attempt to prognosticate the future… and a whole lot of 'food for thought'

Biography Devinder Pal obtained a Master Degree in Pharmacy from the prestigious Banaras Hindu University (standing first in the University) and ‘AMP from AIM-Manila’. Starting as the youngest Production Manager for a leading European group Roussel Uclaf – now Aventis, he rose to be the Whole -time Director. After 13 years of rich and varied experience, he moved on to Parke Davis- Warner Lambert as Vice President & Whole-time Director, responsible for the entire Technical operations, including Quality, R&D, Projects, Logistics – the whole lot – for the next 22 years. Following this he served as Joint Managing Director of Elder Pharmaceuticals. As the founder President & CEO of Catalyst Pharma Consulting for the last 14 years, he is a much sought after Consultant to leading names of Indian and MNCs, as also companies based in the middle east, UK, Europe, Canada, USA, and elsewhere in the world. His focus areas include gap analysis, due diligence, orienting the focus of business, diversification designing and upgrading plants, Cost reduction and efficiency improvement etc. www.CatalystPharmaConsult.com has more. Devinder has served on many national and international forums including the Expert Committee of the USP; Member Indian Pharmacopoeia Committee & Chairman non-parental produts; Drug Technical Advisory Board; Governing Body- Bombay College of Pharmacy; Indian Institute of Packaging; Pharma Pulse; Pharma Biz; Pharma Manager; Pharma Business & Technology; OPPI; PAMDAL; and IDM, etc. Fellow and Life Member, he was the President of the Indian Pharmaceutical Association; National President of the Indian Pharmaceutical Congress, and the Vice President of the UK based prestigious Commonwealth Pharmaceutical Association, etc. and serves with distinction on the elite selection committees, for Lifetime Achievement, Eminent Pharmacist, Fellowship Awards, etc. Thus over the last 5 decades, he has intimately observed from ‘coming into being’ to ‘coming of age’ of Pharma Industry in India, and has, not only participated but, has made notable contribution to the growth of Industry and the Profession. His intuitive, perceptive, analytical and creative approach combined with astute and inspiring leadership is envy of many. No wonder, many who are at the helm of affairs today, attribute their success to him and unabashedly and gratefully acknowledge his role of a ‘guru’, while he sees himself as a ‘chela’. Mr Devinder Pal is recipient of several prestigious awards, which include, ‘Distinguished Alumnus Award’, ‘Pharma Excellence Professional Award’; the ‘Eminent Pharmacist Award’; ‘Lifetime Achievement Award’, Khorana Memorial Award among others. He has been covered in ‘Who’s Who in the World’. [email protected]

Pharmaceut Reg Affairs 2012 ISSN: 2167-7689, PROA an open access journal

Pharma-2012

November 23-24, 2012

Volume 1 Issue 4 Page 168

Pharmaceut Reg Affairs 2012, 1:4 http://dx.doi.org/10.4172/2167-7689.S1.008

2nd International Conference and Exhibition on

Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

Overview of generic drugs review process Durgacharan A. Bhagwat and John I. D’Souza Tatyasaheb Kore College of Pharmacy, India

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he Office of Pharmaceutical Science (OPS) is an integral part of the FDA Center for Drug Evaluation and Research (CDER) new and generic drug product application review process. The office provides uniform policies and review processes for the pharmaceutical industry. A generic drug product is one that is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics and intended use. The OPS laboratory programs support efforts to determine the correct quality standards, and in certain cases, validate the information companies provide. Drug companies, as part of the new drug approval, provide FDA with a list of relevant patents. FDA publishes the patent information and refers generic companies to review patents as part of the research and development process. FDA awards 180 days of exclusivity to the first generic holder to file a complete application (ANDA) with a patent challenge. This exclusivity does not apply against the brand company already in the marketplace but provides protection from other generic competition. FDA has some special issues in the generic review process: consistency among reviews of multiple applications, fairness and timing of reviews, patent and exclusivity issues and demonstration of bioequivalence. The value of generics is the reduction in cost. FDA knows that if a drug costs less, it increases use and prevents shortages resulting from product rationalization or supply disruption. Ultimately, FDA wants consumers to feel confident. Brand or generic, the consumer is getting a FDA-approved product that is interchangeable.

Biography Durgacharan Arun Bhagwat M. Pharm.(Industrial Pharmacy): completed UG from Shivaji University, Kolhapur and PG from SGB Amravati University and pursuing Ph.D. from JJT University, Rajasthan, presently working as Asst. Professor Dept. of Pharmaceutics, Tatyasaheb Kore College of Pharmacy, Warananagar. He has 4 yrs of teaching experience. He published 1 Book and 14 research papers in reputed National and International journals and also presented 40 papers at various national and international conferences. He is Life Member of Indian Pharmaceutical Association (IPA) and Associate Life member of Indian Hospital Pharmacist Association (IHPA). He is Hon. Secretary of IPA Kolhapur Local Branch. He is Executive editor of International Peer reviewed journal “Pharmacum Consequat”. [email protected]

Global patterns of adverse drug reactions over a decade: Analyses of spontaneous reports to vigibase Ebba Holme Hansen

University of Copenhagen, Denmark

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o characterise adverse drug reactions (ADRs) reported to the WHO-ADR database, VigiBase, and to relate data to national income. We analysed ADR reports submitted to VigiBase from 2000 to 2009 with respect to reporting rate, age and sex of patient, type, seriousness and medications. Reports were also analysed with respect to national income level, classified in accordance with the World Bank definition: low, lower-middle, upper-middle and high. We analysed 1,359,067 ADR reports including 3,013,074 ADRs. Sixteen percent of reports were serious and sixty percent were reported for females. High-income countries had the highest ADR reporting rates (range 3 to 613 reports/million inhabitants/year) and low-income countries the lowest (range 0 to 21). Distribution of ADRs across income groups with respect to age group, seriousness and sex was nonsignificant. Overall, the majority of ADRs were reported for nervous system medications, followed by cardiovascular medicines. Low-income countries reported relatively more ADRs for anti-invectives for systemic use than high-income countries, and highincome countries reported more ADRs for antineoplastic and immunomodulating agents than lower-income groups. Highincome countries had the highest ADR reporting rates and low-income countries the lowest. Significant differences in ADR reporting rates were only found for ADRs of the type “skin and subcutaneous disorders” and for the therapeutic groups “antiinfectives for systemic use” and “antineoplastic and immunomodulation agents”. To strengthen ADR reporting rates, especially in low-income countries, more research is needed about the impact of organisational structures and economic resources of national pharmacovigilance centres and ADR reporting practices.

Biography Ebba Holme Hansen has been the professor at the Section for Social Pharmacy, University of Copenhagen since 1992, and has worked for the University since she earned her MSc degree in pharmacy in 1968. She has been the driving force behind the development of social pharmacy as an academic disciplineHer research focus is children's medicine use, psychotropic medicines, adverse drug reactions and the experience and rationale of users in their use of medicines (the user perspective), national drug policy, prescription practices and self-medication, conducted nationally and internationally. Professor Hansen has held numerous posts on national and international committees and boards. [email protected]

Pharmaceut Reg Affairs 2012 ISSN: 2167-7689, PROA an open access journal

Pharma-2012

November 23-24, 2012

Volume 1 Issue 4 Page 169

Pharmaceut Reg Affairs 2012, 1:4 http://dx.doi.org/10.4172/2167-7689.S1.008

2nd International Conference and Exhibition on

Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

Complimentary approaches to metabolic syndrome: Opportunities and challenges Ginpreet Kaur

Narsee Monjee Institute of Management Studies (NMIMS), India

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etabolic syndrome has become a worldwide health problem as it affects more than one third of the population and it sets the stage for catastrophic health problems, such as hyperglycemia, high blood pressure, dyslipidaemia, heart disease, and other age-related diseases. But as a matter of fact, till date in modern medicine there has not been a single drug molecule to mitigate these interrelated states of multiple disorders. Although Diet, exercise, and nutritional supplementation play a key role in its prevention and treatment but it is difficult for patients to follow a diet/exercise regime that would improve their symptoms therefore natural products identified from traditional medicinal plants present an exciting opportunity for the treatment of metabolic syndrome because they contain a wide range of phytochemicals with diverse metabolic effects. We have discovered following plants which were found to be of significant importance such as Lagenaria siceraria with Trigonella foenum graecum for hyperlipidemia, Curcuma longa with piper nigrum and Allium cepa in the treatment of glucose tolerance associated with excess dietary fat intake, obesity and type 2 diabetes due to better safety, tolerability and increased healthcare costs with conventional pharmaceuticals. Globally,, with the advancement of modern medicine there has been a tremendous shift in expanding the horizons of availability of medications from traditional herbs as it has significant potential to deliver next generation medicines for metabolic syndrome with the ultimate goal of maximizing the opportunities and overcoming the challenges.

Biography Ginpreet Kaur has completed her M Pharm (Pharmacology) from Delhi Institute of Pharmaceutical Science and research (DIPSAR), Delhi University and PhD from SPP SPTM SVKM NMIMS University. She is the author and co-author of 16 research and review papers, including three book chapters. She is a member of several professional societies and is presently serving on the Editorial Boards of several scientific journals. Dr. Ginpreet is the recipient of Dr. Ashok B. Vaidya Prize’ and Dr.R.D. Kulkarni Prize” for presenting paper in International Conference Organized by South Asian Chapter of American College of Clinical Pharmacology. [email protected]

Bioadhesive vaginal drug delivery system Gurpreet Kaur

Punjabi University, India

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he vagina, as a site for drug delivery, offers certain unique features that can be exploited in order to achieve desirable therapeutic effects. Considerable progress has been made in this research area over the past few years and, at present, the anatomy and physiology, microflora and secretions of the vagina are well understood. By contrast, the scientific knowledge regarding the possibilities of drug delivery via the vagina is limited. Currently available dosage forms have several limitations, therefore novel concepts and dosage forms are needed. In this field mucoadhesive polymers play a major role. This route coupled with bioadhesion phenomena has born fruitful results in delivering drugs both locally as well as systemically. Bioadhesive vaginal drug delivery system has been used for the treatment of local diseases affecting the vagina like candidiasis, STD, vaginal dryness etc. Also, research has demonstrated that drugs can be successfully delivered to systemic circulation via vaginal mucosa for treatment of various diseases like migraine, osteoporosis. Besides, this vaginal route has also been used for uterine targeting of drugs and in vaccination. The rational design of future formulations needs to include attention to vehicle properties that optimise vaginal coating and retention for a longer period of time.

Biography Gurpreet Kaur did her Ph.D. from Department of Pharmaceutical Sciences and Drug Research, Punjabi University, Patiala, Punjab, India. She is presently serving as Associate Professor in the Department of Pharmaceutics, Punjabi University, Patiala. She has 14 years of teaching and research experience. She has published 20 research papers, and has authored two books. Her main areas of research are colon targeting and bioadhesive drug delivery systems. [email protected]

Pharmaceut Reg Affairs 2012 ISSN: 2167-7689, PROA an open access journal

Pharma-2012

November 23-24, 2012

Volume 1 Issue 4 Page 170

Pharmaceut Reg Affairs 2012, 1:4 http://dx.doi.org/10.4172/2167-7689.S1.008

2nd International Conference and Exhibition on

Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

Understanding facility validation for GMP compliance J. Ramniwas

Sai Pharma Solutions Inc., India

I

n the past decade, many far-reaching changes have taken place in the application of cGMP regulations relating to the pharmaceutical industry. Continuous quality improvement thus is ingrained in the cGMP concept. The design, construction, commissioning, and validation of pharmaceutical facilities play very important role in the risk mitigation of product Quality and Safety. Among the six GMP systems of US FDA requirements for facility system are particularly important for pharmaceutical companies to understand and implement this GMP requirement therefore constructing new facilities and reconstructing the existing ones both require the compliance with the GMP. Facility qualification (a part of validation that proves and documents that equipment or ancillary systems are properly installed, work correctly, and actually lead to the expected results), and validation (establishing documented evidence that provides a high degree of assurance that the manufacturing processes, including buildings, systems, and equipment consistently produce the desired results according to predetermined specifications and quality attributes) activities will establish and provide documentary evidence that the facility suitable for the intended use for manufacturing, testing, storage meeting GMP requirements.

Biography J.Ramniwas has total more than 21 years of experience of working in various Pharmaceutical industries. At present he is the chief executive officer at Sai Pharma Solutions Inc. located at Vadodara, India which is a gateway to the Regulatory Affairs, Quality and cGMP compliance. His experience includes Regulatory Affairs, Analytical Development and Validations, Quality, Establishment of Quality Systems, Regulatory and GMP trainings, Qualifications and Validations of Facilities, Equipments and Utilities, GMP Documentation, Auditing, Regulatory Submissions, Hosting customer and Regulatory Audits, Risk Management and Compliance to Global Regulatory requirements. His articles pertaining to Regulatory Affairs and cGMP compliance issues have been published by many leading pharmaceutical magazines. He is one of the renowned international speaker on GMP and Regulatory Issues. [email protected]

Innovations in developments of gastro retentive drug delivery systems L.D. Patel

C. U. Shah College of Pharmacy & Research, India

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he oral route is the most promising route of drug delivery. Effective oral drug delivery may depend upon gastric emptying process, GI transit & residence time, drug release from DF and site of absorption of drug. Conventional oral dosage forms possess several physiological limitations like variable gastric emptying, variable GI transit & shorter residence time, incomplete drug release from the DF in stomach. It may lead to incomplete & non uniform absorption of the drugs having absorption window in upper part of GIT as once the DF passes down the absorption site, the remaining quantity goes unabsorbed. Hence, a beneficial DDS would be one which exhibits the ability to control & prolong the gastric emptying time and can deliver drug in maximum conc. at the absorption site (i.e. upper part of the small intestine). Pharma world is focusing towards such drugs which require site specificity. Gastro Retentive Drug Delivery System (GRDDS) is one of the site specific deliveries for the delivery of drugs either in stomach or intestine. This can be obtained by retaining dosage form into stomach and drug is released in controlled manner to specific site either in stomach, duodenum or/and intestine.

Biography L.D. Patel is presently Director & Professor at C. U. Shah College of Pharmacy & Research, Wadhwan -363030, Dist.: Surendranagar (Gujarat, India). Dr. Patel has passed B.Pharm., M.Pharm. and Ph.D. in Pharmacy from the world reputed L. M. College of Pharmacy, Ahmedabad, Gujarat. He served at L. M. College of Pharmacy as senior faculty and P.G. Guide in Pharmaceutics. Dr. Patel was Founder Principal & Professor of C. U. Shah College of Pharmacy & Research, Wadhwan. Dr. Patel was also Founder Dean & Professor of Faculty of Pharmacy, Dharmsinh Desai University, Nadiad, Gujarat. He is a member of BOG, Academic Advisory Committee, Standing Committee, and BOS of various organizations. He is an expert to AICTE and Pharmacy Council of India. He is recognized Ph.D. guide in Pharmaceutics in various universities. He has more than 100 research publications in national and international journals. His research interest is in the area of Development of Novel Drug Delivery Systems (NDDS), Patent and Trade marks, Computer & Software Statistical Applications, Direct Compression Formulation &Technology, Dissolution Enhancement, Sustained Release Dosage forms and Transdermal Dosage forms, Artificial neural networks (ANNs) and applications, and Nanotechnology applications. [email protected]

Pharmaceut Reg Affairs 2012 ISSN: 2167-7689, PROA an open access journal

Pharma-2012

November 23-24, 2012

Volume 1 Issue 4 Page 171

Pharmaceut Reg Affairs 2012, 1:4 http://dx.doi.org/10.4172/2167-7689.S1.008

2nd International Conference and Exhibition on

Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

Cassia occidentalis: Effect on skin wound healing in mice induced by Bootrops moojeni venom Leila Maria Leal Parente

Federal University of Goias, Brazil

T

he Bothrops is found in the Americas and are responsible for most snake bites in Brazil. In bite site can occur presence of edema, bruising, redness and hemorrhagic blisters that can progress to necrosis, which affects skin, muscles and tendons. Studies have been developed to minimize local effects caused by Bothrops poisoning, such as use of various substances and therapies, and among them, use of medicinal plants such as Cassia occidentalis (C. occidentalis) commonly used for snakebite. This study was aimed at investigating to evaluate healing activity of ethanol extracts of root and leaves of C. occidentalis in skin wounds in mice induced by the venom of Bothrops moojeni. Extracts were produced by percolation and incorporated into Lanette 10% cream. Cream obtained was administered in skin wounds by seven and fourteen days. Histological evaluations were assessed in these two periods. It was found that extract from leaves of C. occidentalis stimulated angiogenesis and reduced epidermal hyperplasia, acting positively on healing process and minimizing local effects caused by poisonous accident.

Biography Veterinary Medicine, Federal University of Viçosa (1990). She specializes in Science, Federal University of Goiás (UFG) (2000). Master's in Biology, concentration area Animal Physiology by UFG (2004). PhD in Animal Science, concentration area Pathology and Surgery by UFG (2008). She has experience in veterinary medicine, with emphasis on Veterinary Clinic and Complementary Veterinary Medicine. She specializes in Herbal Medicine, Faculty of Pharmacy, UFG (2010). It is scholarship of Scientific and Technological Development Fund (2010-2013), which conducts research to evaluate healing wound activity and ticks control with medicinal plants. She is related to OMICS Groups and Brazilian Animal Science. [email protected]

Occurrence of adverse drug reactions associated with asthma medications in the pediatric population: Qualitative review of studies Lise Aagaard

University of Copenhagen, Denmark

T

o conduct a qualitative, systematic review of empirical studies on the occurrence of adverse drug reactions (ADRs) in the pediatric populations for asthma medications licensed for pediatric use. PubMed, Embase, Cochrane Library, PsycINFO, IPA, and CINAHLs databases were searched from origin until March 2012. Studies reporting ADRs from beta2-receptor agonists, inhaled corticosteroids, leukotriene receptor antagonists and combination products in children from birth to age 17 were included. Information about ADR reporting rates; age and gender of the child, type and seriousness of ADRs, setting, study design, observation period, ADR assessors, authors, and funding sources were extracted from the articles. The review identified 12 studies reporting ADRs associated with medicines for treatment of pediatric asthma in clinical studies. The total population was approximately 3000 children, the majority of 6- to 11-year-old boys. The observation period varied from 1 to 22 months. The most frequently reported ADRs were exacerbation of asthma, respiratory tract infection, cough, fever and headache. Few ADRs were rated as being serious. However, a number of children dropped out of studies due to serious ADRs, and therefore, the number of serious ADRs relative from use of asthma medications is supposed to be larger. Only few studies reporting ADRs from use of asthma medications in the pediatric population were identified in the literature, and these studies reported few types of ADRs only. Pharmaceutical companies should also make all information about ADRs reported for asthma medications licensed for use in the pediatric population accessible to the public.

Biography Aagaard is professor in clinical pharmacy at the University of Southern Denmark. She is working with different aspects of medicine use and health policy, and conducted several studies on medicine use in children and adolescents. She became Msc pharm in 2001, and PhD (pharm) in 2008. From 2001 to 2003 she worked with development of a national evidence based drug-drug interactions database, and from 2004 to 2008 she was employed as a pharmacovigilance officer at the Danish Medicines Agency. Lise Aagaard is editor in chief of the Journal Orphan drugs- research and reviews and member of several editorial boards. [email protected]alth.sdu.dk

Pharmaceut Reg Affairs 2012 ISSN: 2167-7689, PROA an open access journal

Pharma-2012

November 23-24, 2012

Volume 1 Issue 4 Page 172

Pharmaceut Reg Affairs 2012, 1:4 http://dx.doi.org/10.4172/2167-7689.S1.008

2nd International Conference and Exhibition on

Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

Patenting in India –balancing access to affordable medicines and patents for pharmaceutical innovators Manthan D Janodia

Manipal College of Pharmaceutical Sciences, India

T

he issue of intellectual property and in particular patents is a matter of debate. The issue is more important with respect to pharmaceutical patents and various stakeholders which have led to fierce policy debate regarding patenting across the globe and in developing countries in particular. It is argued that patients in developing countries are deprived of access to health as newer medicines under patent are out of reach of millions either due to lack of access or due to prohibitive costs. The flexibilities under Trade Related Aspects of Intellectual Property Rights (TRIPS) are granted to member countries in order to protect public health. One of the flexibilities is granting compulsory license. Various developing countries such as Thailand granted compulsory license in the past in order to protect public health, but till recently India did not use the flexibility of compulsory license. The recent issue of compulsory license in India for Bayer’s anti-cancer drug Nexavar (Sorefenib Tosylate), has opened a pandora’s box. Since, multinational pharmaceutical companies may fear to introduce newer medical therapies in Indian market, it is important to repose their faith in the system so that new medicines are launched in India. Various measures such as monitoring of prices of patented medicines, negotiating the price of a patented medicine by the government before marketing, providing petty patents (utility patents) for minor innovations, procurement of patented medicines by government for public distribution, encouraging healthcare insurance, fostering Industry-Institute partnerships etc. may help balance access to affordable medicines and incentive for innovators.

Biography Manthan D Janodia has completed PhD in Intellectual Property Rights from Manipal University, Manipal in 2009. He is currently working as Assistant Professor in Department of Pharmacy Management, MCOPS, Manipal. He has published research and review articles in national and international journals. He has contributed chapters in book. He has presented papers in various national and international conferences on the topic of Intellectual Property. He is recipient of AICTE travel grant. He is a life member of APTI. He is also reviewer for various journals and is editorial board member of Journal of YoungPharmacists. [email protected]

New drug screening strategy for chronic infectious diseases: The power of common sense Maryse Picher

Consultant Expert at Zintro Inc and CFRX, USA

T

he new challenge faced by the pharmaceutical industry is the development of treatments for chronic diseases combining genetic and environmental factors. Unfortunately, old habits die hard, as most companies still use in vitro drug screening models only reproducing the genetic defects. This presentation provides evidence for the urgent need to develop in vitro models accounting for the genetic and environmental factors to improve clinical trial success. For example, cystic fibrosis (CF) is a genetically-inherited disease which predisposes the patients to chronic airway obstruction and infection. The capacity of a compound delivered by inhalation to improve airway clearance is routinely tested on aseptic cultures of human airway epithelial cells from CF patients. While this high-throughput technique identifies many well tolerated drugs, most of them fail to improve clearance in CF patients. We recently developed a new in vitro model of CF airway disease that incorporates chronic infection. Primary cultures of epithelial cells from CF patients exposed > 3 days to CF sputum developed characteristics that close reproduce the disease, as shown by tissue immunolocalization. The infection caused extensive remodeling of the epithelial barrier lining the airway walls and a polarity shift for several surface proteins, including potential drug targets. This study illustrates the tremendous potential of this new approach to improve the stringency of drug screening, and the success of clinical trials for chronic infectious diseases. This complete in vitro model would “kill” inefficient candidates early in the pipeline, before they enter complex animal protocols and “metabolites in safety testing” (MIST).

Biography Picher is a medical research scientist specialized in drug development for respiratory diseases, with 14 years of experience in drug discovery. As principal investigator at the Cystic Fibrosis/ Pulmonary Research and Treatment Center (NC), she discovered a new signaling pathway regulating airway clearance, currently targeted by Biotech/Pharma. As independent consultant expert for CFRx and Flatley Venture Capital (FVC), she currently provides advices on in vitro models and drug screening protocols, and evaluates the scientific soundness of drugs selected for clinical trials by companies soliciting partnership with FVC. Dr. Picher published 75 scientific documents and is editor-in-chief of a book on drug discovery (Springer, 2011). [email protected]

Pharmaceut Reg Affairs 2012 ISSN: 2167-7689, PROA an open access journal

Pharma-2012

November 23-24, 2012

Volume 1 Issue 4 Page 173

Pharmaceut Reg Affairs 2012, 1:4 http://dx.doi.org/10.4172/2167-7689.S1.008

2nd International Conference and Exhibition on

Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

Overcoming the challenge of differing guidelines for compliance with GMP by different authorities Mithilesh Trivedi

Omni Actives Health Technologies Ltd., India

C

ompliance to GMP is a core requirement for pharmaceutical industry. However, there are number of regulatory authorities controlling the requirement of GMP & each regulatory authority has its own GMP guideline. Hence, complying with such different guidelines is a challenge for an industry. What is GMP? How it is interpreted by the regulatory authority as well as by the inspector during inspection is also important to comply for passing the inspection. What is the approach industry should take for addressing this challenge to comply with the requirement and not going in conflict with the authority/inspector? Following will be discussed during the presentation: • An overview of different regulatory guidelines & their implications on your business • Interpretation by Regulatory authorities/inspectors • What is GMP? • How do inspectors interpret GMP? • Tips and techniques to address and overcome the challenge of differing interpretation of guidelines for complying with GMP

Biography Mithilesh Trivedi has completed his Ph. D. from UDCT (presently known as UICT), Mumbai. He is awarded Fellow of Indian Chemical Society. He has over 28 years of extensive experience in the area of Research & Development, Quality Assurance & Quality Control, and Manufacturing & Operation in Chemical; Fine Chemical; Nutraceuticals; Bulk Drugs and Formulation Industries. He also has extensive experience in product development, process optimization & control, standardizing production norms, GMP, GLP and supplier technical assurance. Mithilesh has also experience in Sterility Pyrogen including BET (LAL Test) and Toxicity Testing and he ensured compliance of various quality measures by maintenance of appropriate requisite documentation/ records. He has successfully handled number of different regulatory inspections and also audited number of sites in India and China. He is also a visiting faculty for Bachelor & Master of Pharmacy for different University & Colleges. He is member of different bodies of Bombay College of Pharmacy, Mumbai. He has attended number of National and International Conferences as participant as well as speaker. He is past President for IPA (Indian Pharmaceutical Association) Branch & presently as Committee Member. He was also Vice Chairman for Technical and R & D Committee for IDMA (Indian Drug Manufacturer’s Association). [email protected]

Pharmaceut Reg Affairs 2012 ISSN: 2167-7689, PROA an open access journal

Pharma-2012

November 23-24, 2012

Volume 1 Issue 4 Page 174

Pharmaceut Reg Affairs 2012, 1:4 http://dx.doi.org/10.4172/2167-7689.S1.008

2nd International Conference and Exhibition on

Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

Facelift of CDSCO Mohammad Shahbaz Alam Meher Pharma International, India

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CG (I) should be independent like USFDA and you can name it Indian Drug Authority (IDA). It should not be controlled by ministry of health. Currently DCG (I) is like a sandwich in between Ministry of Health and Industry. They take care more of MOH and less of industry. Actually, DCG (I) is an ethical facilitator for pharmaceutical and healthcare industry and in real sense DCG (I) is like a mother of industry and his prime responsibility is to nurture industry and bring Indian healthcare on fast forward track to meet their commitment without bribe and approach.DCG (I) should act like revenue generator for MOH and profit generator for industry people. No one can disturb or ignore industry for long period of time because industry has to grow by hook or crook. All healthcare related industries gone down badly because of the poor leadership and unbiased controlling. Huge firing is there in clinical research organization because market is full of uncertainty and there is no work to do. If there is a gut in regulators then they should stop production of unethical production of fixed dose combination of big Pharma giants who are manufacturing since more than a decade without the approval CDSCO. Rather than doing these regulators targeting small growing companies who are financially weak and can shut down. Yes every day small companies are shutting down every day and there is no botheration to the regulators. CDSCO should try to groom small companies by guiding them and assisting them because it is need of the hour. Till now sub regulators have not been fired or transferred by the DCG (I) even after multiple complain by the stake holders. There is no fear of losing job or punishment with the regulators or sub-regulators. For good wishes from the industry people, they become committed for action, otherwise no botheration of whether approval is urgent or very urgent. There should be 360 degree appraisal system in practice for promotion and demotion so that they start caring for all stake holders. Regulators should stop monopolistic approach as there was same attitude earlier of government banks and telecom departments.

Biography He has completed his Ph.D at the age of 32 years from IGNOU and postdoctoral studies from Bhartya Vidya Bhawan, New Delhi, India. He is the managing director & Ceo of Meher Pharma International, a Premier Global Pharma Regulatory Service Organization. His two books have been published by Atalantic publisher New Delhi, India and these books are available for global students in reputed journals. He is serving as an editorial board member of repute jurnal of drug today group. Name of his book is human resource management and contemporary human resource management. [email protected]

Pharmaceut Reg Affairs 2012 ISSN: 2167-7689, PROA an open access journal

Pharma-2012

November 23-24, 2012

Volume 1 Issue 4 Page 175

Pharmaceut Reg Affairs 2012, 1:4 http://dx.doi.org/10.4172/2167-7689.S1.008

2nd International Conference and Exhibition on

Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

Developing regulatory environment in South Asia and challenges for regulatory affairs professionals Nadeem H. Alamgir

Drugs Regulatory Agency, Pakistan

S

outh Asia, is the southern region of the Asian continent, which comprises the sub-Himalayan countries including Bangladesh, Bhutan, India, Maldives, Nepal, Pakistan, and Sri Lanka. It is home to well over one fifth of the world's population, thus is the most densely populated geographical region in the world. This Region includes the countries that were part of the former British Empire including India, Pakistan, and Bangladesh at the core, but also including Sri Lanka, Burma. The Drug Regulations developed by the British during their rule in this region are still the bases of Drug Regulation in these countries. The common issues are a colonial mindset of bureaucracy, lack of resources for capacity building of regulatory authorities/MOH. But the prevailing law gives immense powers to the bureaucrats in these authorities. With new emerging regulations for Pharmaceutical, Medical Devices and Biological Drugs in the developed world, a need for having the same set of regulations is felt by the regulators as well. But the resource constraints and lack of training in emerging of relevant regulations is either nonexistent or painstakingly slow and the authorities are trying to manage in unique ways. Thus becoming a challenge for Regulatory Affairs Professionals as the authorities are coming up with novel ideas nonexistent elsewhere.. To tap the immense potential of this huge market the issues in regulation of the drugs shall be addressed for the benefit of all.

Biography Nadeem Alamgir started his carrier as a Sales Representative in MSD in 1985. He grew over the years in sales in different Pharmaceutical firms and then switched to Regulatory Affairs. While working as regulatory affairs professional he worked with the Government of Pakistan for Pharmaceutical Sector Reforms and amendment of The Drugs Act 1976 of Pakistan, formulation of regulations for Biological Drugs and Medical Devices Regulation. He was instrumental for membership of Pakistan Asian Harmonization Working Party (AHWP) and was able to motivate the authorities to create a separate Medical Device and Biological Drugs department in Drugs Regulatory Agency of Pakistan. He is also the Non Regulatory Primary Member of (AHWP) Asian Harmonization Working Party. [email protected]

Medical representatives with gifts: To whom to give and why Naseem Akhtar Qureshi and Abdullah Al-Bedah Ministry of Health, Saudi Arabia

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edical representatives offer gifts to health providers and managers with their hidden agenda and this behavior could have diverse implications. This presentation aims to address regulatory measures against gifts-derived behaviors both of healthcare providers and pharmaceutical representatives. Using keywords, many rounds of computer searches of PubMed, MEDLINE, Google Scholar and Quertile were made to retrieve relevant peer-reviewed papers published in literature over the past 10 years. Regulatory measures against gift-related behaviors are in place in most of high-income-countries and are followed strictly and USA-FDA is reported to lead the world. The landscape in Eastern world is not at par and needs collective efforts to address this important issue by pharmaceutical giants in collaboration with health authorities. Regulatory checks need to be in sight for controlling the gift-derived behaviors of all stakeholders across the world.

Biography Naseem Akhtar Qureshi has completed his PhD at the age of 48 years from Erasmus University, Rotterdam, The Netherlands and pre-doctoral studies from King George’s Medical College (now King George Medical University), Lucknow. He is the director of Research and Studies Division of General Directorate of Research and Studies, Ministry of Health (MOH) Riyadh Saudi Arabia. MOH is the largest healthcare service organization in Saudi Arabia. He has published more than 120 papers in reputed journals and serving as an editorial board member of 5 repute journals. [email protected]

Pharmaceut Reg Affairs 2012 ISSN: 2167-7689, PROA an open access journal

Pharma-2012

November 23-24, 2012

Volume 1 Issue 4 Page 176

Pharmaceut Reg Affairs 2012, 1:4 http://dx.doi.org/10.4172/2167-7689.S1.008

2nd International Conference and Exhibition on

Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

Corrective action & preventive action (capa system) and regulatory inspection S N Kilikar

Pharma Consultant, India

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APA system is the IMPROVEMENTS to be made in PRODUCT, PROCESS or QUALITY SYSTEMS to eliminate non conformities and other undesirable situation. CAPA is a REGULATORY concept that focuses on systematic INVESTIGATIONS to find out the ROOT CAUSE, understanding and correcting discrepancies while attempting to prevent their REOCCURANCE. Regulatory Inspections gives more importance for CAPA, for the reason, it will high light the systems followed in the company as well as the technical capability of the people concerned. CAPA investigation is set in motion by an event either in manufacturing inconsistency, complaint or regulatory/internal audit. During investigation, it is important that there be system to make sure that the problems are tracked and corrective actions are taken ensuring the quality of the product. Identify the problem and understand its impact on product and reputation of the company.Investigate scientifically to find out the potential cause and arrive at root cause. Extensive documents are required to be checked. All activities and results, in detail, are required to be documented. Once the root cause is identified, analyze the results of findings and confirm. Evaluate the impact of findings in earlier batches of the product. Changes proposed are to be verified and validated to ensure the effectiveness and quality attribution. Inform the details to Management and implement the changes in presence of all concerned in shop floor with proper training. The CAPA system investigation document will give a clear picture of how the QUALITY SYSTEMS works and hence, Regulatory Inspectors give lot of importance to audit this system. REAL ROOT CAUSE IS TO BE IDENTIFIED WITH SCIENTIFIC PROOF AND SHOULD NOT BE GENERATED.

Biography S N KILIKAR has completed his graduation in Chemistry from Kerala University, India in the year 1973. He is having an experience in Pharmaceutical Industry for more than 37 years in the field of QC, PRODUCTION and GMP Implementation including Validation. Now he is working as a CONSULTANT to support Pharmaceutical units to develop new Facilities, Documentation, Validations and other cGMP requirements. He is conducting many Training programmes including for sterile manufacturing. Technical audits are conducted to rectify and upgrade the systems to cGMP level. Three AYURVEDA manufacturing units are set up in Kerala conforming to cGMP standards. [email protected]

Pharmaceut Reg Affairs 2012 ISSN: 2167-7689, PROA an open access journal

Pharma-2012

November 23-24, 2012

Volume 1 Issue 4 Page 177

Pharmaceut Reg Affairs 2012, 1:4 http://dx.doi.org/10.4172/2167-7689.S1.008

2nd International Conference and Exhibition on

Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

Strategies in enzyme engineering - significance, advances and exploiting the benefits of computational approaches Naveen Kulkarni

Polyclone Bioservices Pvt. Ltd., India

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esigner Enzymes and Proteins mimicking evolution on a laboratory timescale can be used to modulate and optimize challenging bimolecular properties such as activity, selectivity, stability, resistance to proteolytic degradation, solubility, etc,. Engineering enzymes and turning them into molecular machineries for producing pharmaceutical product is a billion dollar market. Therefore, the understanding of enzyme-substrate (E-S) relationship and studying the thermodynamics of protein folding is critical for both drug discovery, development and in their production. Rational redesign and directed evolution approach are the two major ways of exploring new properties of a given biomolecule. These approaches are time and resource consuming, shown to produce higher failure rate than success rate, sometimes becomes an iterative process without reasoning. To intervene with greater impact at this point is the use of computational biology which is used not only to predict novel properties of biomolecules but also as a tool to reason and explore the atomic level details responsible for a specific change. The pitfalls of using computational tools are mainly due to inappropriate selection of algorithms and even unreasonable use of such techniques would lead to false positive prediction, meaning just by misinterpreting the output of a docking or a simulation experiment, will yield results that repeatedly fail to deliver in the lab. Unifying different computational techniques, we have developed a framework and experimented on some commercially important proteins. The in silico framework called as enzyme engineering framework (eEF) used for enzyme/protein engineering is a step beyond the SBDD and virtual screening. The framework works sequentially to identify hot spots in enzymes, generate more than a hundred thousand mutations, filter for the most appropriate E-S mutations and simulate E-S reaction to predict the kinetics, activation energies and rate limiting steps of the potential enzyme/protein mutants.

Biography Naveen Kulkarni is the CEO and founder of Polyclone Bioservices Pvt. Ltd. India. He comes with over 15 years of experience covering a broad range of scientific, entrepreneurial and innovation strategies with markets spanning Europe, USA, Australia and India. Prior to this, he served as the Director of Business Development at Philips Research, where he has successfully developed and managed a portfolio of opportunities for New Business Creation across Healthcare and Energy relevant for India, emerging markets and globally. He has conceptualized and developed novel solutions for accelerating drug discovery and directed teams consisting of experts from different domains including chemistry, proteomics and systems biology. He has been instrumental in conceiving new ideas and has several patents to his credit and has presented in various national and international conferences. [email protected]

Pharmaceut Reg Affairs 2012 ISSN: 2167-7689, PROA an open access journal

Pharma-2012

November 23-24, 2012

Volume 1 Issue 4 Page 178

Pharmaceut Reg Affairs 2012, 1:4 http://dx.doi.org/10.4172/2167-7689.S1.008

2nd International Conference and Exhibition on

Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

Design and synthesis of novel antifungal peptides and their mode of action Rajendra Prasad1, Indresh Kumar Maurya1 and Virander Singh Chauhan2 1

School of Life Sciences, Jawaharlal Nehru University, India International Centre for Genetic Engineering and Biotechnology, India

2

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ntifungal peptides as novel therapeutics have raised considerable interest as pathogens frequently acquire resistant against conventional antifungal compounds1. In this regard, developments of antifungal peptides represent an attractive approach2. In the present study, we have investigated the antifungal activity of two classes of novel peptides. One class, de novo designed cationic, amphipathic antimicrobial peptides (AMPs) were inhibitory to the growth of various filamentous and non-filamentous fungi. The FITC tagged AMPs confirmed their rapid entry into the cell that corroborated with the killing time kinetics. Notably, these peptides displayed strong synergism with fluconazole (FLC) which correlated well with the cell death3. The main focus of other class of peptides is based on the structure and function of ABC protein which are overproduced in the resistant cells of Candida albicans4. These overproduced transporter proteins rapidly extrude incoming drugs in resistant strains. We rationally designed and synthesize peptides mimic against 12 transmembrane segments of one of the major drug transporter Cdr1 protein. Our data confirmed that TMS mimics interacted with the Cdr1 protein and blocked the efflux of entrapped fluorescent dyes. These TMS peptides also increased the efficacy of antifungals by blocking of efflux pump. Together, these peptides represent potent novel therapeutics which can be further optimize to become potent antifungals.

Biography Rajendra Prasad earned his Ph.D. in the field of biochemistry at the Agra University in the Central Drug Research Institute. Apart from intermittent research stays abroad he worked at the Jawaharlal Nehru University in New Delhi where he is a full professor at the School of Life Sciences since 1985. His international research experience led him as a research associate to the University of Southern California, School of Medicine, Los Angeles, and to the New York Medical College. He stayed as a Humboldt Fellow and Mercator Professor at the Universities of Bonn, and as a visiting professor in several other countries, e.g. in Spain, Belgium, France and the United States. He has published more than 200 papers in peer reviewed journals and supervised more than 50 PhD theses. [email protected]

Pharmaceut Reg Affairs 2012 ISSN: 2167-7689, PROA an open access journal

Pharma-2012

November 23-24, 2012

Volume 1 Issue 4 Page 179

Pharmaceut Reg Affairs 2012, 1:4 http://dx.doi.org/10.4172/2167-7689.S1.008

2nd International Conference and Exhibition on

Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

Nano technology – a recent trend to sustain development of foliage and novel drug discovery for eco-friendly medicinal plan Raman Dang

Al-Ameen College of Pharmacy, India

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anoscience and nanotechnology are rapidly evolving fields that have potential to revolutionize not only to the food systems but also in the field of agriculture science especially for medicinal plants. It can seek to address some of the critical sustainable development problems in the areas of agriculture, biodiversity, water, energy, health and environment and ecosystem management when it tandem with other measures. Nanotechnology has potential applications in controlling nutrient release and availability, characterization and weathering of soil minerals, soil properties, nutrient ion transport in soil plant system, zeoponics, water conservation, water treatment and efficient management of soil and ground water pollution. Hence nano-fertilizers help to sustain increase of plant growth as compared to normal which lead to accumulation of higher amount of active principles. Even nanoparticles of medicinal herb drugs possess many benefits, such as improving component solubility, enhancement of bioavailability, increasing absorbency of the organism, reducing medicinal herb doses, and achieving steady-state therapeutic levels of drugs over an extended period compared with traditional herb drug preparations. Furthermore, specific surface modifications and new design strategies of herbal drug nano-particles are created to profit clinical applications in cosmetic science and drug discovery.

Biography Raman Dang has completed his PhD at the age 34 years from Bangalore University, India. He is a senior Professor at Al-Ameen College of Pharmacy, Bangalore, India. He has published more than 50 papers in National and International Journals. He has presented more than 60 papers in International and National Conferences and Symposiums. He has chaired many scientific sessions in India and Abroad. He is Associate editor of Bio-Med Journal and on the editorial board of RGUHS Journal of Pharmaceutical sciences, Indian Journal of Pharmaceutical Education and Research (IJPER). He is a member of RGUHS PhD Committee. He has guided more than 45 students for their M.Pharm and 04 Students for their PhD. He is an executive member of Association of Pharmaceutical Teachers of India and Secretary Alumni Association of Al-Ameen College of Pharmacy, Bangalore. [email protected]

Regulatory affairs a challenge to professionals S N Kilikar

Pharma Consultant, India

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egulatory affairs Professionals are having a very important role in Pharmaceutical Industry right from Development and throughout the life cycle of products. In this highly regulated industry, regulatory affairs occupies very crucial role and these professionals should give Strategic and Technical advice to top level Management. Regulatory professionals makes interface between Pharmaceutical Industry and Regulatory Authorities. Regulations laid down by one country need not match the regulations of other country and for export, it is expected that through knowledge of regulation of particular country is necessary to prepare Registration data. The Regulatory professionals should have a good communication skill as they are in contact with every department of the company as well as Regulatory Agencies. Professionals should be aware and retain all relevant worldwide Legislations and Guidelines which may affect the activities of the Organization. CHALLENGES Regulatory professionals should interpret the scope and consequences arising from Legislation and inform Organization accordingly. Submission of accurate Registration Documents to regulatory authorities, otherwise there may be a chance to lose the reputation of the company. Presentation of information collected to the regulatory authorities and feed back their opinion to appraise the staff about current thinking of the Regulatory. Up to date knowledge of changes occurred in the Regulatory system. A broad Analytical frame of mind and collection of latest information will be the success of the Regulatory Professional. Scientifically accurate and knowledgeable professionals will boost the company’s value added reputation.

Biography S N KILIKAR has completed his graduation in Chemistry from Kerala University, India in the year 1973. He is having an experience in Pharmaceutical Industry for more than 37 years in the field of QC, PRODUCTION and GMP Implementation including Validation. Now he is working as a CONSULTANT to support Pharmaceutical units to develop new Facilities, Documentation, Validations and other cGMP requirements. He is conducting many Training programmes including for sterile manufacturing. Technical audits are conducted to rectify and upgrade the systems to cGMP level. Three AYURVEDA manufacturing units are set up in Kerala conforming to cGMP standards. [email protected]

Pharmaceut Reg Affairs 2012 ISSN: 2167-7689, PROA an open access journal

Pharma-2012

November 23-24, 2012

Volume 1 Issue 4 Page 180

Pharmaceut Reg Affairs 2012, 1:4 http://dx.doi.org/10.4172/2167-7689.S1.008

2nd International Conference and Exhibition on

Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

Diversity oriented approaches to unusual amino acid derivatives and peptides-Implications in drug discovery Sambasivarao Kotha

Indian Institute of Technology Bombay, India

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his talk covers our work about new methodologies developed in our laboratory regarding unusual amino acid derivatives. During the past couple of decades our group has engaged in design and synthesis of unusual amino acid derivatives and peptides. We have used modern synthetic strategies to prepare the required amino acid based building blocks and modified peptides. Some of these include enyne metathesis, cross-metathesis, Suzuki coupling, Diels-Alder reaction, [3+2] cycloaddition and [2+2+2] cyclotrimerization. In addition, we have also used rongalite as a useful green reagent for the preparation of benzosultine derivatives, which are the latent precursors to o-xylylene intermediates. These advances in designing new methodologies will impact the synthesis of modified amino acid derivatives and peptides and ultimately in drug discovery process.

Biography Sambasivarao Kotha graduated with M.Sc. degree in Organic Chemistry from University of Hyderabad and obtained Ph.D. in synthetic organic chemistry from University of Hyderabad in 1985. He continued his research at university of Hyderabad as a postdoctoral fellow for one and half year. Later, he moved to UMIST Manchester UK and University of Wisconsin as a research associate. Subsequently he was appointed as a visiting scientist at Cornell University and research chemist at Hoechst Celanese Texas prior to joining IIT Bombay in 1994 as an assistant professor and presently he occupies. Pramod Chaudhari Chair for Green Chemistry and Industrial Biotechnology His research interests include organic synthesis, development of new synthetic methods for unusual amino acids, peptide modification, and Green Chemistry. He is a recipient of B. M. Birla Science Prize (1996), Bronze Medal, Chemical Research Society of India (2004), Bhagyatara National Award-Punjab University (2005), Prof. Y. T. Thathachari National award-Bhramara trust-Mysore (2010) and J. C. Bose Fellowship (2010), Fellow of the Indian Academy of Sciences and National Academy of Sciences India and Fellow of Royal Society of Chemistry. He also serves on the Editorial Advisory Board of Indian Journal of Chemistry, Journal of Amino Acids, and Catalysis Journal. [email protected]

Pharmaceut Reg Affairs 2012 ISSN: 2167-7689, PROA an open access journal

Pharma-2012

November 23-24, 2012

Volume 1 Issue 4 Page 181

Pharmaceut Reg Affairs 2012, 1:4 http://dx.doi.org/10.4172/2167-7689.S1.008

2nd International Conference and Exhibition on

Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

PEGylation products, mono and combination therapies- Increasingly clearing regulatory hurdles and reaching market Sandeep Arora and Arvind sharma Chitkara university, India

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riginating as a novelty, PEGylation technology introduced by Davis and Abuchowski in the late 1970s, has undergone a shift from academic to industrial interest in recent years. The practical importance of the procedure is clearly demonstrated by the numbers of protein-PEG conjugates reaching the market or making it to an advanced state of clinical experimentation. Examples of commercialised products using PEGylation are Adagen®, Oncaspar®, PEGIntron®, PEGASYS®, Neulasta® and Somavert®, and a dozen other PEG-proteins which are now in advanced clinical trials. PEGylation, which started from protein modification, now includes delivery of oligonucleotides, genes, microparticles, liposomes and living cells and interferones. This continuing interest for new applications is well documented in over five hundred patents filed so far in the field, a situation which is not paralleled by any other polymer of pharmaceutical application. The success of PEG modification of proteins is, in a way, imitating nature's post transcriptional modification of proteins to expand and differentiate their role. It is probable that this strategy is not exclusive for poly ethylene glycol, as recent studies using polymers of natural origin such as polysaccharides and synthetic polymers have demonstrated. The present review is focused on regulatory requirements related to innovation in field of PEG technology for delivery of bioactives and increasing use of such products as combination therapies to cover various possible ramifications of a disease. In case of PegIntron, on December 22, 2011, the Food and Drug Administration approved revisions to the product labeling for PegIntron to include the use of PegIntron with hepatitis C virus (HCV) NS3/4A protease inhibitors for the treatment of genotype 1, chronic hepatitis C (CHC) infection and in patients with neuropsychiatric disorders. The best way to use PegIntron in this indication is in combination with ribavirin in the form of Rebetol tablets. The combination dose titration may be an important issue, e,g., on May 8, 2009, FDA approved updates to the package insert for PegIntron combination product, adding a two-step dose reduction scheme for PegIntron and increasing the dose of Rebetol to 1200 mg/day for patients who weigh between 81 and 85 kilograms. Same is the case with other products. Oncaspar® is indicated as a component of a multi-agent chemotherapeutic regimen for the first line treatment of patients with ALL. These apart, for regulatory clearance, it is of prime importance that during the discovery phase the structure and PEGylation site, the PEG characteristics, the stability, the biological efficacy and duration are well defined. The developmental plan following the guidelines for both preclincal and clinical study should be related to the “innovation level” of the product.

Biography Sandeep Arora, Director of Chitkara College of Pharmacy. He has a professional experience of around 16 years (3.5 years of Pharma Production and Quality Assurance and 16 years of Teaching/Training, and research) in the field of Pharmacognosy and Natural Products. He has to his credit editorial and authorship assignments as Hon. Editor – Advanced Drug Review (a quarterly drug pharmacology review index) since 2005, authored book titled “Pharmaceuticals- Issues for Industrial Management” and has 40 national and international research publications. He attended 20 conferences, out of which 4 are international. His area of specialization and research is medicinal natural products (phytochemical, pharmacological evaluation and standardization) and development and regulatory aspects of herbal and other products and industrial management. [email protected]

Pharmaceut Reg Affairs 2012 ISSN: 2167-7689, PROA an open access journal

Pharma-2012

November 23-24, 2012

Volume 1 Issue 4 Page 182

Pharmaceut Reg Affairs 2012, 1:4 http://dx.doi.org/10.4172/2167-7689.S1.008

2nd International Conference and Exhibition on

Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

SGLT-1: A Novel target for drug development in cardiomyopathy and heart failure Sanjay K Banerjee

Indian Institute of Chemical Technology, India

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arget-based drug discovery has become the prevailing paradigm used by pharmaceutical and biotechnology companies. This approach is attractive as it holds the promise of identifying newer and more-efficacious compounds with fewer undesirable side effects. Target identification and validation technologies form a critical foundation for modern drug discovery. These approaches provide a rich source of intellectual property and can be valuable competitive differentiators for companies seeking proprietary positions for drugs that act through novel mechanisms. Inhibiting sodium–glucose co-transporters (SGLTs), which have a key role in the reabsorption of glucose in kidney, has been proposed as a novel therapeutic strategy for diabetes. The development of inhibitors targeted against SGLTs grew out of experiments with the compound phlorizin, which was first isolated in the 1800s and was found to improve blood glucose levels in laboratory animals. While SGLT2 has been established as a potential target for diabetes, SGLT1 has not shown much effectiveness against diabetes. However, our recent data indicated that SGLT1 highly expressed in heart and plays an important role in cardiomyopathy. In the mammalian heart, glucose transport is believed to be mediated mainly by two members of the GLUT family, GLUT1 and GLUT4. Whereas GLUT1 is regarded as a basal glucose transporter, GLUT4 is upregulated in response to insulin and mechanical work. In addition to the GLUT family, members of the sodium/glucose cotransporter (SGLT1) mediates glucose uptake in normal and disease heart. Although SGLT1 is highly expressed in the heart, its cardiac function has been investigated recently. I will discuss my journey to find a novel target, SGLT1, for the opportunity to develop drugs against cardiomyopathies and heart failure.

Biography Sanjay K Banerjee has completed his Ph.D in 2003 from Division of Pharmacology, All India Institute of Medical Sciences, New Delhi and postdoctoral studies from SUNY Upstate Medical University, Syracuse, USA (2003-2005) and University of Pittsburgh, Pittsburgh, USA (2005-2009). He is a Scientist and Ramalingaswami Fellow (DBT, Govt. of India), in the Division of Pharmacology, Indian Institute of Chemical Technology, Hyderabad. He is also a guest faculty in NIPER, Hyderabad. He has published more than 30 papers in reputed journals. He is member of D&CVD, a study group of European Association for the Study of Diabetes (EASD). [email protected]

Pharmaceut Reg Affairs 2012 ISSN: 2167-7689, PROA an open access journal

Pharma-2012

November 23-24, 2012

Volume 1 Issue 4 Page 183

Pharmaceut Reg Affairs 2012, 1:4 http://dx.doi.org/10.4172/2167-7689.S1.008

2nd International Conference and Exhibition on

Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

Optimising the bang for buck in the realm of therapeutic ontology using patent and XP documents Sankar Sundaram and Shubhankar Joshi

Department of Pharmaceutical Chemistry, JSS University, India

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t is becoming harder and harder to discover a new Drug. A part could be attributed to “the low-hanging fruits have already been plucked” maxim and another part to the huge expenses involved in the design, synthesis, preclinical and clinical evaluation of a new therapeutic intervention. It is therefore, desirable to reduce the cost of Drug Discovery by adopting low-cost outsourcing of custom-synthesis, cost-effective and sure-shot screening methods, bedrock Safety-profiling etc. Before committing one’s resources to the above Business development strategy, it is advisable to thoroughly estimate the elbow room available under one’s command. Enter the Patent and XP Documents, whose gleaning, determines the first step in ascertaining the metes and bounds of business risk propensity. A few case studies are being discussed, to get an insight of smarter staking in the realm of New Drug Development business.

Biography Sankar Sundaram, the son of a Registered Nurse, has completed his PhD in Pharmaceutical Sciences, from The Tamil Nadu Dr MGR Medical University and Bachelor of General Laws’ from the Annamalai University. He is a Registered Patent agent (IN/PA-666) in the Indian Intellectual Property Office and has drafted more than fifteen patents pertaining to the field of Pharmaceutical Products. Currently, he is guiding PhD scholars in New Drug Discovery and is teaching Medicinal Chemistry for graduate students at the JSS University, Mysore. [email protected]

Population pharmacokinetics and its relevance to pharma Industry Shobha Rani R Hiremath

Al-Ameen College of Pharmacy, India

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apidly evolving changes in health care economics and consumer expectations make it unlikely that traditional drug development approaches will succeed in the future. There is a need to focus on the implementation of pharmacokineticpharmacodynamic (PK-PD) studies and modeling as essential tools for drug development. Population pharmacokinetics (PPK) has evolved from therapeutic drug monitoring and plays a key role in clinical pharmacology and drug development. PPK methods are used throughout the drug development process to summarize the data and most importantly for phase II and III studies in the efficient development of safe and effective drugs. PPK combined with simulation methods helps in estimating the expected range of concentrations for the given dose. The PPK study plan for each drug development project must have a strategy for data management, data collection, data quality assurance, staff training for data collection, data analysis and model validation. The application of population approaches to drug development is recommended in several US Food and Drug Administration (FDA) guidance documents. Population pharmacokinetic analyses may be undertaken in 3 steps: exploratory data analysis, model development and model validation. Documentation for regulatory purposes should include a complete inventory of key runs, accompanied by objectives, assumptions, hypotheses and diagnostic analyses of goodness of fit as evidence of reliability of results. The use of the population approach by the pharmaceutical industry needs to be encouraged to provide valuable information not obtainable by other techniques. The acceptance of population PK-PD analyses by regulatory agencies also needs to be encouraged.

Biography Shobha Rani R Hiremath has 25 years of teaching experience, guided 47 M. Pharm and 9 Ph.D students. She has attended more than 80 conferences/workshops in India and abroad. She has 75 national and international publications. Dr. Shobha Rani has 2 patents to her credit. She has achieved several grants and awards in her career and she is a consultant to various pharmaceutical industries. Dr. Hiremath is the secretary of Independent Ethics Committee in Bangalore Allergy Centre, Bangalore. She is the Editor-in-chief of the quarterly journal entitled “Indian Journal of Pharmacy Practice” published by Association of Pharmaceutical Teachers of India, India. [email protected]

Pharmaceut Reg Affairs 2012 ISSN: 2167-7689, PROA an open access journal

Pharma-2012

November 23-24, 2012

Volume 1 Issue 4 Page 184

Pharmaceut Reg Affairs 2012, 1:4 http://dx.doi.org/10.4172/2167-7689.S1.008

2nd International Conference and Exhibition on

Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

Cool clot, a novel haemostatic agent for controlling life-threatening arterial bleeding SMJ Mortazavi

Shiraz University of Medical Sciences, Iran

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ncontrolled bleeding is the first leading cause of preventable death in the battlefield and the 2nd cause of mortality in civil accidents. Incompressible hemorrhage control is among the interventions that drastically increase the survival rate in wounded individuals. We have previously shown that a certain mixture of bentonite and zeolite minerals can significantly decrease the bleeding in rats. In this study, five healthy hybrid dogs were selected and after induction of anesthesia with ether, either arterial puncture by a needle or arteriotomy was performed on both groin regions of the dogs. For control arteries (either right or left femoral artery), only pressure by sterilized gauze was performed, while for the femoral arteries of the opposite side, our invented haemostatic agent, namely CoolClot, was topically used before applying the pressure. In the second stage of the study, to assess the coagulation time, blood samples were collected from 10 volunteer students. CoolClot significantly decreased the bleeding time in animals whose femoral arteries were cut or punctured. In the human phase of the study, the mean coagulation time in control blood samples was 253.4±44.1 sec, while for blood samples treated with bentonite, zeolite and CoolClot it was 149.5±50.0, 162.3±74.6 and 143.4±114.6 sec, respectively (p