The New First-in-Human EMA Guideline: Disruptive or Constructive? Outcomes From the First EUFEMED Discussion Forum

• Main Authors: Kerstin Breithaupt-Grögler (Author), Tim Hardman (Author), Jan de Hoon (Author), Yves Donazzolo (Author), Sylvie Rottey (Author), Hildegard Sourgens (Author), Steffan Stringer (Author)
• Format: Book
• Published: Frontiers Media S.A., 2019-04-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

The European Federation for Exploratory Medicines Development (EUFEMED) organized a meeting in Leuven, Belgium entitled 'The new FIH EMA guideline: Disruptive or constructive?' to provide a forum for stakeholders to discuss the guideline's operational impact. The revised EMA Guideline...