Clinical Trials Regulation and the Clinical Trials Information System (CTIS) EMEA webinar

19-12-2021 / Daniela van 't Ent - Ifrim / Legislation

If you have missed the EMA webiner from 29NOV2021 regarding the upcoming CTIS, there is still a chance to acces the slides on EMA wesbite, here.

The scope of the webinar was to inform pharmaceutical companies and academic sponsors of clinical trials on how to prepare for the main changes brought by the Regulation.

Topics presented during the webinar included:

  • Clinical Trials Regulation overview
  • Process of submitting clinical trial information in the EU/EEA
  • Functionalities of CTIS (e.g transparency aspects and safety reporting)
  • Guidance and training material for sponsors