FDA-EU Kickoff Two-Day Bilateral Meeting

The FDA welcomed EU health authorities to its White Oak Campus in Maryland today for a two-day FDA-EU Bilateral meeting.

The FDA, the EU's Directorate for Health and Food Safety (DGSANTE) and the European Medicines Agency (EMA) have enjoyed a long history of collaborating via these meetings on a host of subjects and maintain a regular meeting cadence. Each meeting offers a unique opportunity to hold technical discussions on emerging or high-priority topics. This year, for the first time, the European Food Safety Agency (EFSA), the European agency that provides independent scientific advice and communications on existing and emerging risks associated with the food chain, is joining the meeting in reflection of both the FDA’s and the EU’s commitment to the principles of One Health, which acknowledges the interconnection of human, animal, and environmental health.??

FDA Deputy Commissioner for Policy, Legislation, and International Affairs Kimberlee Trzeciak kicked off this year's meeting. "I am confident that this FDA-EU bilateral meeting will build on our strong and longstanding collaboration and will contribute to meaningful steps forward to advance our partnership as global leaders," she said.

Both Dr. Marco Marsella, Director for Digital, EU4Health and Health Systems Modernisation for the EU's Directorate for Health and Food Safety (DG SANTE), and Dr. Namandjé? Bumpus, FDA Principal Deputy Commissioner, delivered opening remarks.

"These discussions provide us a unique opportunity to come together – to strengthen our relationships, our understanding, and our capacity to affect important change," said Dr. Bumpus., who then moderated a "Bilateral Leadership Dialogue." Topics discussed included food priorities, both the FDA's and the EU's opportunities and challenges for the next five years, potential bilateral cooperation and how a One-Health approach impacts their work and activities.

In the room with Dr. Bumpus were Rebecca Buckner, Acting Deputy Director for Regulatory Policy, Nutrition, and Engagement, at the FDA's Center for Food Safety and Applied Nutrition, and Guilhem de Seze, Head of EFSA's Risk Assessment Production Department. Participating virtually were Sabine Pelsser, Head of Unit for Antimicrobial Resistance and Human Nutrition, DG SANTE, and Jonathan Briggs, an EC policy officer. ?

Today’s other sessions include emerging science in food; new technologies for food outbreaks, including the use of whole genome sequencing; new alternative methodologies for risk assessment; artificial intelligence; digital health; and evidence generation. Tomorrow’s bilateral will focus solely on medical product topics.??

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