Revised FIH EMA Guideline: Disruptive or Constructive?

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Yves Donazzolo
Results of the EUFEMED Survey as compared with the Club Phase 1 Survey

Joop van Gerven
EMA Guideline FIH 2018

Jan de Hoon
Introduction to the EUFEMED Forum

Stefano Ponzano
EMA Scientific Advice on FIH studies

Hildegard Sourgens
Results of the EUFEMED Survey as compared with the Club Phase 1 Survey

Kirsty Wydenbach
UK Experience of First-in-human Trials

You were invited to attend EUFEMED’s first interactive forum at KU Leuven.

The faculty contained a wide range of industry and academic experts and seven representatives from the European regulatory authorities:

• Dr. Sonja Beken, FAGG-AFMPS Brussels, Belgium
• Prof. Dr. Joop van Gerven, CCMO, Den Haag, Netherlands
• Dr. Sarah Heil, BfArM Bonn, Germany
• Dr. Marc Martin, ANSM Paris, France
• MUDr. Ondřej Palán, SUKL Prague, Czech Republic
• Dr. Stefano Ponzano, EMA
• Dr. Kirsty Wydenbach, MHRA, London, UK

Thank you for working with us to achieve the best possible implementation of the revised FIH EMA guideline.