Prequalification: Training material

EAC/TFDA/WHO training for East Africa Community National Medicine Regulatory Authorities staff on
      assessment of dossiers based on WHO Prequalification guidelines.

       Dar-es-Salaam, United Republic of Tanzania,  10 - 14 September 2007 

       Background information [pdf]
       Programme [pdf]

                 
Presentations:

Monday, 10 September 2007

• Principles of regulation of medicinal products with special attention to interchangeable products [ppt]

• Overview of dossier requirements and guidelines [ppt]

• Active Pharmaceutical Ingredients (APIs) [ppt]

Tuesday, 11 September 2007

• Finished Pharmaceutical Products (FPPs) - 1 [ppt]

• Finished Pharmaceutical Products (FPPs) - 2 [ppt]

• Manufacturing Process [ppt]

• Comparative dissolution testing and applications [ppt]

• Stability testing [ppt]

Wednesday, 12 September 2007

• Overview of quality evaluation issues [ppt]

• Introduction to the concept of bioequivalence testing - bioavailability vs. bioequivalence [ppt]

• Introduction to the concept of bioequivalence testing - innovator vs. generic [ppt]

• Bioequivalence [ppt]

• Regulatory requirements for BE [ppt]

• Selection of comparator products [ppt]

• Planning a BE study [ppt]

Thursday, 13 September 2007

• Statistical considerations [ppt]

• Complicated issues [ppt]

• Analytical methods [ppt]

• Waivers of in vivo BE studies [ppt]

• Quality of BE study [ppt]

• Examples of problems in bioequivalence studies [ppt]

Friday, 14 September 2007

• WHO Prequalification Programme: example of available regulatory expertise for some medicinal products [ppt]

• Involvement of countries in the Prequalification Programme [ppt]

• Working with expertise available from other regulatory authorities [ppt]