Simplifying Global Compliance
FDA and EU Inspections – Webinar Recording/Transcript
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FDA and EU Inspections — The Mutual Recognition Agreement: What’s Next?
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.
Presentation Takeaways:
- MRA Timeline: The Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 and what it has led to
- Benefits so far: How inspectors are using each other's inspections to maintain a risk-based approach ... potential benefits for U.S. drug safety
- And costs: How the MRA may complicate regulatory and compliance operations ... which inspections FDA will continue to perform ... which will go to EU member states
- What’s next for: FDA capability assessments ... possibility of duplicating the MRA model in other regions ... potential impact of ‘Brexit’ on the MRA
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—
- C-Suite executives
- Multinational drugmaker executives
- Regulatory Affairs
- Compliance
- Quality Assurance/Quality Control
- Legal Affairs
- Consultants/Service Provider
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.
