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?

PROGRAM

Moderator: Izaak den Daas, QPS, The 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

Click here for more information and registration

This is the first of four 2022 EUFEMED webinars. Also the next two webinars will address relevant topics in relation to the Clinical Trial Regulation and the last one, in Q4, will invite to learn about a highly innovative clinical pharmacology topic. Register for all four and pay only for three webinars.