GMP Webinar: The MRA with the U.S. - The End of FDA Inspections in the EU?

GMP Webinar: The MRA with the U.S. - The End of FDA Inspections in the EU?

Seminar Nr. 16252


Kosten

Die Veranstaltung hat bereits stattgefunden

Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Sprecher

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.

Hintergrund

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.

Zielgruppe

The webinar targets executives and staff in the pharmaceutical industry, who want to get a comprehensive overview of the agreement and its consequences.

Technical Requirements

For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.
At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programm

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?

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