Prequalification: Training Material

Pharmaceutical Quality, Good Manufacturing Practice and Bioequivalence with a Focus on TB products

       Jiaxing, P.R. China,  5 - 9 November 2007 

       Background information [pdf]
      

      Programme (English)  [pdf]
      Programme (Chinese) [pdf]

Presentations (English & Chinese Versions Below):

Monday, 5 November 2007

• Prequalification Programme & Chinese Version [ppt]

• Introduction: Dossier requirements and guidelines & Chinese Version  [ppt]

• Active Pharmaceutical Ingredients (APIs) & Chinese Version [ppt]

• Good Manufacturing Practice (GMP) - Quality Assurance & Chinese Version [ppt]

• Good Manufacturing Practice (GMP) - Premises & Chinese Version [ppt]

Tuesday, 6 November 2007

• Good Manufacturing Practice (GMP) - Quality Control & Chinese Version [ppt]

• Good Manufacturing Practice (GMP) - Validation & Chinese Version [ppt]

• Finished Pharmaceutical Products (FPPs) & Chinese Version  [ppt]

• Comparative Dissolution Testing & Chinese Version  [ppt]

Wednesday, 7 November 2007

• Marketing authorization through equivalence documentation & Chinese Version  [ppt]

• Experimental design of bioequivalence studies & Chinese Version [ppt]

• Planning a BE study & Chinese Version [ppt]

• Statistical considerations for BE studies & Chinese Version [ppt]

Thursday, 8 November 2007

• Sample analysis for a comparative bioavailability study & Chinese Version [ppt]

• Regulatory requirements for BE & Chinese Version [ppt]

• Issues regarding bioequivalence & Chinese Version [ppt]

• Choice of comparator product & Chinese Version [ppt]

• Additional considerations (English & Chinese)  [ppt]

• Assay methods/Validation of Analytical methods & Chinese Version  [ppt]

• Waivers of in vivo BE studies & Chinese Version  [ppt]

Friday, 9 October 2007

• Quality of bioequivalence studies & Chinese Version [ppt]