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: 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

This session will help you to plan and prepare properly for the meeting after a decision to seek advice is made. The session will discuss in-depth understanding and equip you with the right skill set for a successfully conducted meeting.
The session will include a “Preparing the right questions” group exercise.

Initial planning and preparations from an industry perspective
What kind of questions should be asked incl. group exercise
Meeting requests and meeting packages EU and FDA

Speaker(s)

PLANNING, PREPARING AND MANAGING THE MEETING – EMA & FDA

Birka Lehmann, MD

Birka Lehmann, Germany

Senior Expert Drug Regulatory Affairs

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EU Health Authorities Scientific and Regulatory Advice

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

Session Chair(s)

Birka Lehmann, MD

Trine B. Moulvad, MSc

Speaker(s)

PLANNING, PREPARING AND MANAGING THE MEETING – EMA & FDA

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