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Session 3: Progress of the EU-US cooperation on the Mutual Recognition Agreement for pharmaceutical Good Manufacturing Practices
Session Chair(s)
Stephan Roenninger, DrSc
Director, Quality External Affairs
Amgen (Europe) GmbH, Switzerland
Facilitating public health by freeing inspection resources for industry and national competent authorities and ensuring high quality medicines for patients in an environment of trade negotiations.
Speaker(s)
Introduction: Progress of the EU-US Cooperation on the Mutual Recognition Agreement for Pharmaceutical Good Manufacturing Practices
Stephan Roenninger, DrSc
Amgen (Europe) GmbH, Switzerland
Director, Quality External Affairs
FDA International Engagement and the US-EU Mutual Recognition Agreement
Matthew Scherer, MBA
U.S. Food and Drug Administration, Belgium
Assistant Attache, FDA-Europe Office
EU-US MRA Practical Implementation
Andrei Spinei, MPharm, MSc
European Medicines Agency, Netherlands
Scientific Administrator
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