Clinical Research India 2008 Presentations

Click in the presenter’s name to download the presentation.

Preconference Workshop — Sept. 23

Navigating the Waters of the Clinical Trials Application Process in India
Ira Gupta, M.D., Director, Clinical Development, Oncology Medicine Development Center, GlaxoSmithKline
Vijai Kumar, M.D., President and Chief Medical Officer, Excel Life Sciences, Inc.
Michael Eckstein, President, Topaz Clinical Services

Day 1 — Sept. 24

Conducting Clinical Trials in India: Potential and Pitfalls
Falguni Sen, Ph.D., Professor of Management, FordhamUniversity and Pharmaceutical Industry Consultant

Does India Have the Bandwidth and Qualifications to Effectively Conduct Your Clinical Trials? What You Need to Know to Move Forward
Vijai Kumar, M.D., President and Chief Medical Officer, Excel Life Sciences, Inc.

Evaluating Key Emerging Markets for Improved Strategy: Regulations, Growth Trends, Leaders and Challenges Panel Discussion
Mak Jawadekar, Ph.D., Director, WWPPM, Pfizer Global R&D

What is the FDA’s Perspective and Expectations on U.S. Companies Conducting Research in India?
Wayne Pines, President of Regulatory Services and Healthcare, APCO Worldwide

Inside India Sites — Surprising Facts You Need to Know
Saurendra Das, M.D., Country Head and Director of Operations, Excel Life Sciences

Day 2 — Sept. 25

Understanding the Patient and Cultural Considerations for Conducting Studies in India … NEWDATA REVEALED from an informed consent survey of India patients!
Dan McDonald, Vice President, Business Strategy, Excel Life Sciences

Global Studies and Emerging Markets — Considerations for Success: Sponsor Case Study II
Jennifer Carothers, MBA, ScD, Associate Director, Clinical Management, Ortho-McNeil Janssen Scientific Affairs, LLC

Avoiding Mistakes in Selecting an Outsourcing Partner to Conduct Clinical Trials
Dinkar Saran, Principal, PRTM Management Consultants

Understanding the Impact of Increased Regulatory Oversight on Clinical Trials in India
Linda Horton, Partner, Hogan & Hartson, LLP

Postconference Workshop — Sept. 25

Understanding India's Regulatory Bodies Governing Clinical Research
Sandeep Athalye, M.D., Director, Translational Medicine, Exploratory Development, Novartis Pharmaceuticals Corp