Delhi Summit 2007 - Scientific Program - Session IV

Chairs:
Dr. Ganguly, Director General ICMR, New Delhi, India
Dr. J. Fareed, Professor, Loyola University Medical Center, USA
Dr. G. Rao, Professor, University of Minnesota, USA

04:50 - 05:00 PM Recommendations for Approval of Generic Drugs such as Antithrombotics
W. Leong - Walter Jeske - E. Kalodiki
05:00 - 05:10 PM Limitations of Current Guidelines
G. Rao - M. Walter Jeske - E. Kalodiki
05:10 - 05:20 PM Ongoing Discussions on Biosimilar - Biogeneric and Biotechnologic Drugs
C. Jackson - F. Ofosu
05:20 - 05:30 PM Regulatory Agencies and Their Position in North America
R. Hull - R. Wahi - W. Leong - A. Sasahara (Corresponding)
  Regulatory Agencies and Their Position in Europe W. Raake - E. Kalodiki - B. Kaiser
05:40 - 05:50 PM Regulatory Agencies and Their Position in South East Asia
R. Saxena - V. Muthuswamy (Deputy Director, ICMR)
05:50 - 06:00 PM Regulatory Agencies and Their Position in Central and South American
H. Nader - R. Altman (Corresponding)
06:00 - 06:10 PM Position of the Professional Organizations (EU, ICAT, SASAT, ASH, ACCP, ACS)
J. Fareed - I. Hussain - A. Nicolaides (Corresponding)
06:10 - 06:20 PM Position of the Industry and Pharmacopeial Organizations
P. Bianchini (European Pharmacopeial Commission)
U. Cornelli (Corresponding)
06:20 - 06:40 PM Summary and Recommendations for the White Paper
Moderators: J. Fareed - G. Rao - R. Hull - W. Leong
Panelists: Cecil Ross, Das Gupta, Reena Das,
Sharath Damodar, Renu Saxena, Dipika Mohanty, Vijay Arora,
Anjali Arora, Sateesh Babu, Rakesh Wahi
06:40 - 06:45 PM Closing Remarks
Dr. J. Fareed, Professor, Loyola University Medical Center, USA

 

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