Eufemed webinar – Early Phase Trials under the EU Clinical Trial Regulation


2023 – When the CTR will be in force for all – Let’s be prepared

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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?

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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 incl. F, D, BE, NL, PL

17:25 – General discussion

17:45 – Closing remarks

This is the first of four 2022 EUFEMED webinars. The next two webinars will also 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.

Attendance fees (excl. VAT):

  • Member of a EUFEMED organisation:  € 30.00
  • Non-member: € 60.00
  • Member of a EUFEMED organisation(4 webinars): € 90.00
  • Non-member (4 webinars) : € 180.00

Recognised EUFEMED member organisations include: Healixia (formerly the Belgian Association for Phase-I Units; BAPU, Belgium), Association Française de Pharmacologie Translationnelle (formerly Club Phase I, France), the Association for Applied Human Pharmacology (AGAH, Germany) and the Association for Human Pharmacology in the Pharmaceutical Industry (AHPPI, United Kingdom).

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