Prequalification: Training Workshop

WHO workshop on assessment of bioequivalence data submitted to regulatory authorities

       Kiev, Ukraine,  26 - 30 October 2009 

The training workshop on assessment of interchangeable multisource medicines (generics) was organized for bioequivalence assessors in East European and Central Asian countries. Finally, 31 assessors from 11 target countries attended the workshop.

The workshop was organized by WHO prequalification of Medicines Programme in close collaboration with WHO Regional Office for Europe and was effectively supported by the State Pharmacological Centre of the Ministry of Health of Ukraine. Focus was given on use of theoretical knowledge in evaluation of study reports and writing assessment reports.

• Training Programme - English [pdf]
  

• Training Programme - Russian [pdf] 
  

Presentations:

Monday, 26 October 2009

• Interchangeability testing and BE design studies & Version in Russian [ppt]

• Selection of comparators & Version in Russian [ppt]

• Statistical considerations & Version in Russian [ppt]

• Analytical considerations & Version in Russian [ppt]

• Regulatory requirements for bioequivalence and existing guidelines & Version in Russian [ppt]

• Presentation of BE data in product dossier & Version in Russian [ppt]
  

Tuesday, 27 October 2009

• Quality of bioequivalence data & Version in Russian [ppt]

• BE study assessment & Version in Russian [ppt]

• Most frequent deficiencies in submitted data and GCP & Version in Russian [ppt]

• Introduction into the work on case studies & Version in Russian [ppt]

Wednesday, 28 October 2009

• Biowaivers, Biopharmaceutical Classification System & Version in Russian [ppt]