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Session 8 Track B: MRA Implementation: Implementation of the EU-FDA GMP Mutual Recognition Agreement (MRA): FDA Update and Industry Survey Results
Session Chair(s)
Andrew Chang, PhD
Vice President, Quality and Regulatory Compliance
Novo Nordisk, United States
By February 2019, 22 EU member states were assessed by US FDA on their capability and qualified. At this session, a representative from FDA will share their experience and perspectives on the implementation of the MRA. Industry representatives from both sides across the Atlantic Ocean will share their results from the MRA implementation benchmarking survey.
Learning Objective : At the conclusion of this session, participants should be able to:- Describe the progress of implementing the EU-FDA MRA
- Summarize the perspectives and experience from the FDA and the regulated industry on implementation of the MRA
Speaker(s)
The MRA Implementation: FDA’s Perspective and Experience
Brian Hasselbalch
FDA, United States
Deputy Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER
MRA Implementation - European Industry View
Stephan Roenninger, DrSc
Amgen (Europe) GmbH, Switzerland
Director, Quality External Affairs
The MRA Implementation: Industry’s Perspective and Experience
Andrew Chang, PhD
Novo Nordisk, United States
Vice President, Quality and Regulatory Compliance