FDA and EU Inspections – Webinar Recording/Transcript
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.
- 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!