Working Group on Regulatory Matters meets in Bergisch-Gladbach

In early July, the second meeting of the BIO Deutschland Working Group on Regulatory Matters took place in Bergisch-Gladbach. The experts informed themselves about the new measures unveiled by the European Medicines Agency (EMA) and about adapative pathways. In addition, meeting participants discussed the work being done to develop a uniform German model contract for investigators as well as two current EMA initiatives:

  • EMA consultation on the Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol and
  • EMA action plan to support small and medium-sized enterprises (SMEs) as drivers of pharmaceutical innovation (“SME Office annual report 2016”).

The meeting also gave special attention to advanced therapy medicinal products (ATMP). Here, participants discussed the progress made in further developing the legal and regulatory framework for ATMP.

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