EU Health Authorities Scientific and Regulatory Advice

NEW OFFERING! The course is built up as a dialogue between industry and regulator perspective and will teach you what authorities pay attention to, what inquiries they make and what they expect to hear from sponsors.

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SESSION 2 CONTINUED: PLANNING, PREPARING AND MANAGING THE MEETING – EMA & FDA

Session Chair(s)

Birka Lehmann, MD

Senior Expert Drug Regulatory Affairs

Birka Lehmann, Germany

Trine B. Moulvad, MSc

Global RA, Medical Documentation and R&D QA

Lundbeck, Denmark

Storyline and key messages
Rehearsals and Challenges
How does the Agency prepare?
Do’s and don’ts – how to conduct the meeting

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