Chicago, Il, USA
Course No 16240
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Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org
This event is designed by QPs and international experts as a forum with focus on sharing information and experience and on discussing the critical areas of European GMPs and the QP’s daily work.
The Pharmaceutical Industry is becoming more global due to international collaborations, mergers and acquisitions and more complex supply chains requiring companies to have a greater understanding of pharmaceutical legislation throughout the world. This is becoming increasingly evident by the number of non EU professionals contacting the European Compliance Academy and the Qualified Persons Association asking for more and more detailed information about the European GMPs and the unique role and responsibility of the EU QP.
The ECA Academy and the European QP Association, recognizing this need for further professional knowledge development, intend to support the pharmaceutical industry outside Europe in understanding the European approach and legal framework in this respect. Therefore, the QP Association has set up the programme at hand on European GMP requirements and the role of the QP.
In light of the establishment of a Mutual Recognition Agreement between US and EU and the parallel move out of Great Britain from the EU, representatives from the authorities as well as QPs and well-known experts will talk about the current issues and share their point of view. Various case studies will be presented and discussed to come up with possible solutions.
Make use of this event by exchanging experiences with your colleagues and by establishing informal contact and networking.
I would like to invite you to this unique opportunity, and I look forward to meeting you.
Best regards,
Ulrich Kissel
Chairman of the European Qualified Person Association
The Conference has been designed for non-EU QA and QCU personnel, upper management functions and authority representatives who want to be informed about the latest development regarding European GMPs and the duties and responsibilities of Qualified Persons.
The presentations of this conference will be available for download and your print-out 1 week before the conference. You will also receive a USB stick at the conference’s registration desk.
Note: there will be no print-outs available during the conference.
Please also read The Impact of the changing EU Guidance and the MRA.
Introduction: The ECA and the European QP Association
Part 1: Understand European GMPs
The EU Pharmaceutical GMP-/GDP Legislation & Facts on the Mutual Recognition