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Browsing Tag

batch release

2 posts

EMA’s consultation on draft Q&As on remote certification of batches by QP

by Giuliana Miglierini The last two years saw the implementation of a high degree of regulatory flexibility as…

Revision of the PIC/S GMP Guide: Annex 13 and Annex 16

by Giuliana Miglierini The entry into force of EU Regulation 536/2014 “Clinical trials”, at the end of January,…
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