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NH Berlin Alexanderplatz

24 abr 2017 8:00 a.m. - 24 abr 2017 4:30 p.m.

Landsberger Allee 26-32, 10249 Berlin, Germany

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.

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

Session Chair(s)

Birka  Lehmann, MD

Birka Lehmann, MD

Patient Expert

University of Bonn, Germany

Trine B. Moulvad, MSC

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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