CT CURE Training Session

CT CURE will conduct the training session titled ‘Emergency Preparedness through Platform Trials in the EU-EEA’. This session is a part of our collective initiative to improve the evaluation of platform trials, drawing on insights from clinical trial applications for COVID-19 treatments.

The training is designed specifically for assessors of clinical trial applications from Medical Research Ethics Committees (MREC) and National Competent Authorities (NCAs). It is scheduled to occur on September 5th and 6th in Brussels.

Background & objectives

CT CURE  is an EU4Health joint action of Member States funded by the European Union that aims to establish a network of MREC, and NCAs that gain experience on conducting expedited assessment of clinical trial applications on COVID-19 therapeutics.

The CT CURE vision and rationale is an accelerated, harmonised regulatory review of clinical trials to facilitate rapid generation of clinical data on novel therapeutic strategies in public health emergencies.

In order to increase emergency preparedness in EU/EEA this training focusses on the regulatory review of large platform trial applications bringing assessors from both Ethics Committees and National Competent Authorities together. The training is open to all Member States in EU/EEA and part of the Training Work Package 7 for CT CURE.

Aims and learning objectives

The overall aim of the training program is to increase the capacity and readiness of MREC and NCAs in the EU-EEA to review and approve platform trials for pandemic preparedness and response.

  • Plenary Setting: To understand the rationale, design and methodology of platform trials, identify key regulatory and ethical issues an challenges adopting a harmonized and proportionate approach for the expedited review process in EU/EEA Member States of clinical trial applications in public health emergencies.
  • Break-out Session Setting: Discussion sharing experiences and reviewing public health emergency case studies among assessors from EU MREC and NCAs with the aim to propose additional steps to expedite and harmonise reviews while ensuring regulatory scientific and ethical excellence.

Target audience

The training program is intended for clinical trial application assessors from MREC and NCAs in the EU-EEA, who are involved in the review and approval of clinical trials. We aim for a balanced representation of MREC and NCAs from different countries, both members and non-members to CT CURE.

📅 Date:  Sept. 5-6

📍 Location: Brussels

🎓 Facilitated by: CT Cure, EU4Health

Special instructions

  • Each consortium member (BE, CZ, DE, EL, ES, FR, HR, HU, LT, LV, NL, PT, RO, SE, SI) will nominate four participants for reimbursement.
  • We anticipate the participation of two experts from the National Competent Authority and two experts from the Ethics Committee for each consortium member.
  • The national contact points of member states that are not part of the consortium will nominate two participants for reimbursement, preferably one expert from the National Competent Authority and one from the Ethics Committee.
  • Additional attendees are welcome, subject to maximum capacity. Please note that reimbursement is not available for these participants.
  • In consultation with the CT CURE consortium member of your country, or with the national contact point for non-consortium members, we will inform you about your registration by 28th June.

Your participation is crucial to our shared objective of establishing a more resilient and agile healthcare system. Kindly RSVP by June 20th to confirm your attendance.

We eagerly anticipate your valuable contribution to this important initiative.

Please confirm your attendance before 20th June by submitting the registration form.

Check out the program.