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Prequalification: Workshop
Beijing, P.R. China - 29-30 March 2010. Post-conference workshops: 31 March 2010
The
Conference on Quality of Active Pharmaceutical Ingredients
(API) was organized in cooperation with the World Health
Organization (WHO), the European Directorate for the Quality
of Medicines (EDQM) and the State Food and Drug
Administration (SFDA)'s
The
two-day conference was attended by more than 140 industry
and regulatory participants.
Presentations were made about requirements of WHO,
EDQM, SFDA, EMA and US FDA regarding APIs and about
experience from conducted inspections.
The
conference was followed by workshops on WHO Prequalification
of Medicines
Programme and EDQM Certification Scheme (CEP) which were
attended by over 70 participants.
In addition, a
specific workshop was organized by WHO for manufacturers of
anti-tuberculosis medicines in order to inform them about
specific quality issues relevant for development and
production of medicines in this therapeutic category
(especially fixed dose combinations) and about existing
programmes, strategies and needs of international sponsors
and procuring organizations like Gates Foundation, Global
Fund for AIDS, Malaria and Tuberculosis and UNITAID. Programme Conference (29-30 March 2010) Programme Workshops (31 March 2010)
Monday, 29 March 2010
Tuesday, 30 March 2010
Wednesday, 31 March 2010 - Workshops WHO Prequalification Programme
The EDQM's Certification of Suitability (CEP) Procedure
Quality of Essential antituberculotic medicines
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Conference on Quality of Active Pharmaceutical Ingredients