Prequalification: Training material

WHO Prequalification Programme Meeting on Priority Essential Medicines

       Cairo, Egypt  6 - 7 June 2007 

Background Information [pdf]

Programme [pdf]

      
Presentations:

Wednesday, 6 June 2007

• Prequalification Programme: overview, objectives, procedures, partners & stakeholders [ppt]

• Principles of Regulation [ppt]

• Good Manufacturing Practices - Purpose & Principles of GMP [ppt]

• Good Manufacturing Practices - GMP related guidelines  [ppt]

• Good Manufacturing Practices - monitoring GMP compliance, inspection experience, technical assistance [ppt]

Thursday, 7 June 2007

• Dossier requirements for generic medicines: quality (part I) [ppt]

• Dossier requirements for generic medicines: quality (part II) [ppt]

• Bioequivalence studies: regulatory requirements on conduct, documentation of BE studies [ppt]