Expert workshop on process validation for the manufacture of biotechnology-derived active substances

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TitleExpert workshop on process validation for the manufacture of biotechnology-derived active substances
Date09/04/2013 - 09/04/2013
LocationEuropean Medicines Agency, London, UK
SummaryThis workshop addresses key questions concerning specific evaluation / validation data, which are required to confirm the reproducibility and robustness of the manufacturing process of biotechnology-derived active substances and ultimately guarantee a product of consistent high quality at the time of evaluation of the marketing authorisation. The event brings together experts and provides useful reference for the future European Medicines Agency guideline on process validation for the manufacture of biotechnology-derived active substances.

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Contact point:

Alberto Ganan Jimenez
alberto.ganan@ema.europa.eu