About EUFEMED webinar: Early Phase Trials under the EU Clinical Trial Regulation - What changes in the interaction between competent authorities and ethics committees?
EUFEMED webinar: Early Phase Trials under the EU Clinical Trial Regulation - What changes in the interaction between competent authorities and ethics committees?
2023 – When the CTR will be in force for all – Let’s be prepared
The EU Clinical Trial Regulation has come into force on 31 January 2022. Although primarily aiming at making the EU a more attractive place for clinical research by facilitating and speeding up the approval process in multi-national trials, many national changes to authorisation and supervision of mono-national clinical trials are now applicable. The CTA application process including the structure of the CTA dossier is now identical in all EU and EEA countries. But the Regulation leaves it up to the Member States to organize the joint dossier assessment by competent authorities and ethics committees. How is this now working in practice in different countries? What is the impact on the review?
Moderator: Izaak den Daas, QPS, Netherlands
16:00 - Welcome and Introduction
16:10 - An overview of changing aspects for national Phase 1 trials under the EU Clinical Trial Regulation + Q&A - Ingrid Klingmann, Pharmaplex BV, Belgium
16:35 - How are EU Member States organizing collaboration between competent authority and ethics committee in the trial authorization process? + Q&A - Round Table discussion with Sébastien Vanhiesbecq (Belgium), Thomas Sudhop (Germany), Claire Bahans (France), Anne Moulin (France), Pieter de Graeff (Netherlands) and Izaak den Daas as moderator.
17:25 - General discussion
17:45 - Closing remarks
This is the first of four 2022 EUFEMED webinars. Register for all four now and pay only for three webinars.
- 16 September 2022 (16:00-17:30 CET): Submitting an application for a CTA or Substantial Modifications and what do sponsors from outside the EU need to consider
- 4 November 2022 (16:00-17:30 CET): Reporting obligations under the Clinical trial Regulation: SUSARS, Serious Breaches, Summary of Trial Results and Lay Summary of trial results via CTIS
- 9 December 2022 (16:00 - 17:30 CET): Christmas Lecture: Latest innovations in early medicines development
Member ticets are available for members of:
Association of Human Pharmacology in the Pharmaceutical Industry (AHPPI - UK), Healixia (Belgium), Association Française de Pharmacologie Translationnelle (AFPT – France), Association for Applied Human Pharmacology (AGAH - Germany), Associatie van Contract Research Organisaties in Nederland (ACRON - Netherlands)