8:30 SWOT Analysis of Pharmacovigilance, PMS and PSUR in India

Y.K. Gupta, Head, Dept. of Pharmacology; Coordinator, Zonal Pharmacovigilance Centre, All India Institute of Medical Sciences
With India becoming a preferred destination for global clinical research, the strengthening of Pharmacovigilance and enforcement of post marketing surveillance and
Periodic Safety Updates has become important. National Pharmacovigilance program with its three tier system of Zonal, Regional and Peripheral centres across the country is picking up but needs to be supplemented and complimented by pharmaceutical industry and professional bodies. The attendees will learn:

• A SWOT analysis of the current status of pharmacovigilance activities in India

• The action plan to create the much required human resource, strategies for conducting timely and reliable PMS studies

• Increasing coordination between regulators, physicians and the pharmaceutical industry in India to harmonize the pharmacovigilance activities

• Harmonization of PSUR between ICH and Schedule Y of drugs and cosmetics act in India

• Guidelines for pharmacovigilance and timeframe for PMS and PSUR in India

9:00 Safety Reporting in India Clinical Research Environment
Kamala Rai, M.D., Research Director, MSD Pharmaceuticals Pvt Ltd; Medical Director, Merck (India)
As India continues to increase enrolling more Indian patients at clinical research sites, the safety reporting and all attributes that impact this endpoint are an important topic for review and reflection. Critical to this piece of monitoring is understanding the trends, the culture of pharmacovigilance and the management of both serious and non-serious adverse events.

• Implementation of good PV practices at Indian sites

• How to manage adverse experiences

• Role of IRB/ECs and agencies

• Tools and technology that will help sites in implementing PV practices

9:30 The Strategic Planning Behind the Clinical Site Allocation in Emerging Economies: An Industry-Wide View

Fabio Thiers, M.D., M.Sc., Ph.D., Research Associate, MIT Center for Biomedical Innovation, MIT
This objective description of industry-wide trends will inform discussions on the
strategic choices made by industry officials in the allocation of clinical sites in emerging economies, especially India, China, and Southeast Asia.

• Characterize country-specific strategies of planners of global clinical development programs

• Employ extensive data on global geographic distribution of clinical sites to depict the choices made by industry officials in the allocation of trials of different stages and therapeutic areas

• Describe the characteristics of the trials going to each major emerging country/region, showing how different countries preferentially attract certain types of trials

10:00 Technology Spotlight (Sponsorship Available)

10:30 Poster Competition & Refreshment Break in the Exhibit Hall

11:30 Country and Site Selection for Global Clinical Trials

Fidela Ll. Moreno, M.D., Executive Director, Global Development Operations, Asia and Latin America, Amgen Inc.
Patient access and recruitment is an issue that is high on the list of factors affecting clinical trial timelines. Patient recruitment can be difficult, especially in the face of competing trials, escalating operating costs, increasing regulatory requirements and more complex studies. There is pressure on many sponsors to maximize the potential of a clinical study, and many are looking toward the emerging regions of Asia and Latin America to increase their recruitment capabilities. Incorporating emerging regions into clinical development plans, however, has its unique set of challenges ・intellectual property protection, standards of medical care, data quality, ethics and regulatory hurdles, to name a few. These challenges make it difficult to determine where, when and how to expand clinical operations. This presentation will demonstrate how one company made that decision and implemented their global expansion plans.

12:00 Interactive Panel #2

Effectively Identifying, Selecting and Engaging Clinical Sites Fidela Ll. Moreno, M.D., Executive Director, Global Development Operations, Asia and Latin America, Amgen Inc. Chandrashekhar Potkar, M.D., Director, Clinical Research, Pfizer Ltd. (India) Michael Shi, Director and Biomarker Project Leader, Exploratory Oncology Development, Novartis Oncology Fabio Thiers, M.D., M.Sc., Ph.D., Research Associate, MIT Center for Biomedical Innovation, MIT

12:30 Luncheon Workshop (Sponsorship Available) or Lunch on Your Own

1:30 Break

1:45 Chairperson's Remarks

1:50 Best Practices for Engaging Regulatory Authorities in Asia

Sudhir Srivastava, Ph.D., MPH, M.S., Chief, Cancer Biomarkers Research Group, Division of Cancer Prevention, National Cancer Institute
With the rapid evolution of clinical infrastructures and the patient base, India is poised to contribute to the development of experimental drugs and clinical evaluation of therapy through organized, scientifically designed clinical trials. Although the ethical and regulatory landscapes are still evolving, the good news is that these institutions are aligning themselves to already accepted guidelines and criteria for a successful clinical trial in the West and tailoring their regulatory needs to meet the local concerns and societal needs. There is no best practice or guidelines to navigate through the regulatory landscapes in India. However, the knowledge of funding agencies and regulatory institutions will be of a great value to seek pre-trial requirements and identify partners in India. The Speaker will address some of his experience in dealing with cancer hospitals and government institutions to plan for clinical trials in India.

2:20 Recent Regulatory Changes in India

Chandrashekhar Potkar, M.D., Director, Clinical Research, Pfizer Ltd. (India)
Regulatory environment in India is evolving rapidly. The government has announced plans to establish a central drug authority on the lines of US FDA to create one regulatory systems for pharmaceutical R&D. This initiative coupled with amendments to drugs & cosmetic act, proposed legislation in biomedical ethics, plans to initiate inspections for clinical trials, simplification of approval process are notable examples of conducive regulatory environment in India. In this presentation, the speaker will provide an overview of current regulatory environment in India and discuss case studies on approval process for new chemical entities, biologics, devices and products with alternative systems of medicine.

Navigating the Regulatory Landscape throughout Asia

	Chet Elias, Sr. Manager, Global Regulatory Affairs & Safety, International Expansion, Amgen Inc.
	James Cai, M.D., Vice President, R&D, AstraZeneca Pharmaceuticals, China
	Y. K. Gupta, Head, Department of Pharmacology, All India Institute of Medical Sciences
	Sudhir Srivastava, Ph.D., MPH, M.S., Chief, Cancer Biomarkers Research Group, Division of Cancer Prevention, NCI
	Brijesh Regal, C.E.O., Apothecaries Clinical Research, New Delhi, India (Former WHO Consultant to Drugs Controller General of India, and coordinated the development of Schedule Y)