Prequalification: Workshop

Training workshop on Assessment of Interchangeable Multisource Medicines

       Mombasa, Kenya - 10-14 August 2009

A training workshop on assessment of interchangeable multisource medicines was organized for assessors from Drug Regulatory Authorities in East Africa countries.  The objective of the workshop was to train assessors from regulatory authorities in East Africa in the regulatory evaluation of interchangeable multisource (generic) medicines, enhance their cooperation and support the Kenyan regulatory authority in effective organization of dossier assessment and implementation of CTD.

The workshop was organized by WHO Prequalification of Medicines Programme in close collaboration with the Pharmacy and Poisons Board of Kenya and WHO Country Office in Kenya.  Altogether, 33 assessors from 8 countries (Kenya, Uganda, Tanzania, Rwanda, Botswana, Zambia, Zimbabwe and Ethiopia) attended.

Programme [pdf]

Tuesday, 11 August 2009

• General aspects of quality assessment of multisource interchangeable medicines [ppt]

• Active Pharmaceutical Ingredients [ppt]

• Manufacturing process and validation [ppt]

• Dissolution testing [ppt]

• FPP specifications [ppt]

Wednesday, 12 August 2009

• API stability [ppt]

• FPP stability [ppt]

• Validation of control methods [ppt]

• FPP assessment and deficiencies [ppt]

Thursday, 13 August 2009

• Interchangeability and study design [ppt]

• Selection of comparator [ppt]

• BE Study Assessment - Practical Issues [ppt]

• Statistical considerations [ppt]

• Analytical considerations [ppt]

• Regulatory requirements [ppt]

• Presentation of data in BE dossier [ppt]

• Quality of BE Data [ppt]

Friday, 14 August 2009

• Health Canada/US FDA Favourite Links [ppt]

• Bioequivalence assessment in the European Union [ppt]

• BCS-Biowaivers [ppt]

• BCS-Biowaivers - Template [ppt]