Thursday October 9th Schedule SASAT 2008

Welcome: Professor Gundu H. R. Rao
Introduction: Professor Jawed Fareed


Second International Summit on Generic Low Molecular Weight Heparins

Developmental, Regulatory and Clinical Issues
(Organized in cooperation with: IUA and IACATH)

Objectives: To review the current recommendations from various professional organizations (IUA, I-CATH, NATF and SASAT) to approve generic antithrombotic drugs in particular generic low molecular weight heparins. In addition, we will also review the positions of US FDA, EMEA, USP, EP and other regulatory bodies on this matter.

Topics for Discussion:

  1. Status of generic low molecular weight heparins development
  2. US FDA's position on the development of generic low molecular heparins
  3. EMEA's position on the development of low molecular weight heparins
  4. Requirement for the immuno-equivalence for the LMW heparins
  5. Requirement for the clinical trials to prove the bioequivalence of low molecular weight heparins.
  6. Impact of heparin containment on the development of low molecular weight heparins
  7. Shortage of heparins
  8. Other generic low molecular weight heparins

This summit will also review the draft version of the white papers, which was developed during the 2007 international summit on generic antithrombotic drugs at New Delhi, India.

Chairs: Job Harenberg and Jawed Fareed
Moderators: Richard Kennedy and Gundu Rao
Recording Secretaries: Evi Kalodiki and Wendy Leong

Cultural Program and Dinner
Cponsored by Medefil, USA

(*Note: Time allotted for each presentation is 20 minutes)

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