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Virtual Event

23 sep 2020 1:00 p.m. - 25 sep 2020 5:30 p.m.

(Central Europe Standard Time)

4051 Basel, Switzerland

Advancing CMC Workshop

Session 3: Progress of the EU-US cooperation on the Mutual Recognition Agreement for pharmaceutical Good Manufacturing Practices

Session Chair(s)

Stephan  Roenninger, DRSC

Stephan Roenninger, DRSC

Director, Quality Compliance 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)

Stephan  Roenninger, DRSC

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 Compliance External Affairs

Matthew  Scherer, MBA

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

Andrei  Spinei, MPHARM, MSC

EU-US MRA Practical Implementation

Andrei Spinei, MPHARM, MSC

European Medicines Agency, Netherlands

Scientific Administrator

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