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

• 主要な著者: Kerstin Breithaupt-Grögler (著者), Tim Hardman (著者), Jan de Hoon (著者), Yves Donazzolo (著者), Sylvie Rottey (著者), Hildegard Sourgens (著者), Steffan Stringer (著者)
• フォーマット: 図書
• 出版事項: Frontiers Media S.A., 2019-04-01T00:00:00Z.
• 主題: article
• オンライン･アクセス: 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...