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On 2nd March 2017, the U.S. Food and Drug Administration FDA and the European Medicines Agency EMA informed that they concluded a so-called MRA (Mutual Recognition Agreement). Such agreements are intended to mutually recognise GMP inspection systems and accept the respective inspections. The agreement shall cover both medicinal products and APIs. Some CBER regulated products like human blood, human plasma, human tissues and organs, and veterinary immunologicals are excluded from the scope of the agreement. The new agreement should come into force on 1st November 2017. Until then, the FDA wants to review the authorities of further EU countries.
This webinar aims at giving you a comprehensive overview about the agreement and to explain the details. Furthermore, ambiguities, possible consequences and open questions are discussed:
Scope, exceptions, particularities
Specifics with investigational medicinal products (IMPs)
Interfaces with Annex 16 and the planned Annex 21 of the EU-GMP Guidelines
Control of imported materials, testing and batch release
The future of GMP certificates
Quality Metrics: still needed?
The webinar targets executives and staff in the pharmaceutical industry, who want to get a comprehensive overview of the agreement and its consequences.
Dr Rainer Gnibl,GMP Inspector, District Government of Upper Bavaria, Germany
Dr Rainer Gnibl is pharmacist and GMP Inspector for the District Government and the EMA and performs GMP inspections worldwide. Before that, he was working for the Bavarian Ministry of Environment and Health. Rainer Gnibl also holds a lectureship at the University Erlangen-Nürnberg.