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NH Berlin Alexanderplatz

Apr 24, 2017 8:00 AM - Apr 24, 2017 4:30 PM

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 3: WHAT HAPPENS AFTER THE AGENCY MEETING/FEEDBACK

Session Chair(s)

Birka  Lehmann, MD

Birka Lehmann, MD

Senior Expert Drug Regulatory Affairs

Birka Lehmann, Germany

Trine B. Moulvad, MSc

Trine B. Moulvad, MSc

Global RA, Medical Documentation and R&D QA

Lundbeck, Denmark

  • Debrief
  • Meeting minutes
  • What does the advice received mean and how it should be used? How to apply the learnings from the meeting and follow up where necessary
  • Transparency

Speaker(s)

Trine B. Moulvad, MSc

WHAT HAPPENS AFTER THE AGENCY MEETING/FEEDBACK

Trine B. Moulvad, MSc

Lundbeck, Denmark

Global RA, Medical Documentation and R&D QA

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