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From 07-09 June 2011, the first joint conference of the European Compliance Academy and European QP Association was held in Bethesda, Maryland. The Conference attracted delegates from all over the U.S. who were given the opportunity to inform themselves about the latest development regarding European GMPs and the duties and responsibilities of the Qualified Persons according to the European regulations. This joint Conference was designed by QPs and international experts as a forum with a focus on sharing information and experience and on discussing the critical areas of European GMPs and the QP's daily work. Speakers from FDA, EMA and the European QP Association presented latest developments, current issues and shared their point of view. During two post-conference sessions covering batch release and investigational medicinal products,, various case studies were presented and discussed to come up with possible solutions.
Some highlights of this major event are summarised on the website of the European Qualified Person Association. Besides the huge amount of information provided, the delegates made use of this event by exchanging experiences with speakers and colleagues and by using the networking possibilities. This was also shown by the feedback the organisers got. Here are a few examples: - "The conference was very informative and provided significant information regarding QP role and associated regulations"
- "Great way for teaching US colleagues about QP role"
- "The openness and access to the speakers was great."
- "I will definitely recommend this course to colleagues"
- "This was a great event! Great information with great discussions."
Based on all of this, the European Compliance Academy decided to offer this conference on the Impact of EU Directives and Guidelines on the Supply Chain in Bethesda, Washington D.C. Metro Area, USA, 27-28 June 2012. Wolfgang Schmitt
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)
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