Prequalification: Training material

Training course

Training Workshop on Pharmaceutical Quality and Bioequivalence - Hanoi, Vietnam,  17 - 19 January 2006 

Agenda [pdf]

Presentations:

• Procedures for Participating in the Prequalification Programme [ppt]

• PQIF - API [pdf]

• PQIF - FPP [pdf]

• Site Master File (SMF) [pdf]

• Introduction to the Discussion of Bioequivalence Study Design and Conduct [ppt]

• Experience from the Evaluation of Drug Dossiers with Respect to Bioequivalence Data [ppt]

• Additional Considerations [ppt]