Dr Rainer Gnibl, GMP Inspector
One might easily get the impression that the GMP world is continuously turning faster. Laws, regulations, and especially GMP requirements of the EU are constantly renewed, modernised and (allegedly) adapted against each other. The effects of the pandemic and the Brexit bring additional demands. To provide you with an overview is thus the goal of this webinar.
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.
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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:
- New developments in the EU
- EU-GMP Guidelines and Annexes
- Quality requirements for Investigational Medicinal Products (IMPs)
- Regulation (EU) 2019/6 on Veterinary Medicinal Products - GMP relevant aspects
- Corona and its consequences:
- Impact on inspections (EU and FDA)
- Ongoing consequences of Brexit
- News from FDA und ICH
- Outlook for 2023