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One might easily get the impression that the GMP world is continuously turning faster. Laws, regulations, and especially GMP or GDP requirements of the EU are constantly renewed, modernised and (allegedly) adapted against each other. To provide you with an overview is thus the goal of this webinar.
This webinar aims at giving you a comprehensive but still compact overview about the many innovations in the GMP area – those already realised and those planned:
EU-GMP Guide (e.g. Annexes 1, 17, 21)
The FDA/ EU MRA (and the future of the Quality Metrics Initiative)
The extended MRA with Japan
News from Europe (e.g. update ATMP guidance)
Update Elemental Impurities guidance
New EU Clinical Trial Regulation and guidance
The webinar targets executives and staff in the pharmaceutical industry, who want to get a compact but yet comprehensive overview of all recent changes in the GMP requirements.
Dr Bernd Renger
Dr Renger is Immediate Past Chair of the European QP Association. Prior to that he was VP Quality Control at Vetter Pharma-Fertigung GmbH. He began his career at Hoechst AG in 1977 and has held various management positions in the quality area at Mundipharma, Byk Gulden (today Takeda), and Baxter BioScience AG in Vienna.