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FDA and EU Inspections — The Mutual Recognition Agreement: What’s Next?
Want to attend the live webinar on Sept. 27? Click here to register.
It’s been seven years since FDASIA was enacted and the path to globalized GMP inspections of drugmakers is complete at last. The Mutual Recognition Agreement (MRA) provides for inspection cooperation among the FDA and the 28 member nations of the EU. So ...
What happens now???
Are good things on your horizon ... or glitches ... or both? Two leading Washington consultants, Cynthia Schnedekar Esq. and Elizabeth (“Liz”) Oestreich Esq. of Greenleaf Health Inc. are your guides on a 90-minute exploration of the new inspections landscape.
Drugmaking today is a global business. Even if EU sales represent a small portion of your sales now, that can change down the road. Protect yourself!
Drugmakers with global operations will find this Webinar more than timely. Specific job titles include but are not limited to—
Cynthia Schnedar Esq., Executive Vice President, Regulatory Compliance, Greenleaf Health Inc.
Ms. Schnedar is former Director of the FDA Office of Compliance, Center for Drug Evaluation and Research (CDER), where she led a staff of more than 300 and spearheaded efforts to ensure compliance with federal quality and safety standards.
Elizabeth (“Liz”) Oestreich Esq, Vice President, Regulatory Compliance, Greenleaf Health Inc.
Ms. Oestreich served as Director of Educational Programming for the Food and Drug Law Institute (FDLI) and was Editor-in-Chief of the Food and Drug Law Journal.
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