European Medicines Agency / Emergency Task Force and European Commission workshop on lessons learned on clinical trials in public health emergencies

• Date:
  Friday, 09 June 2023
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

Event summary

On 9 June 2023, EMA organized a Lessons-learned workshop on Clinical Trials in Public Health Emergencies.

The aims of the workshop were to:

• Review current processes for clinical trials during emergencies
• Explore actions that could expedite approval process of multinational EU trials
• Define a framework for a more integrated framework for clinical trials during and in preparation of emergencies with the aim of fostering larger multinational clinical trials.

The workshop post-workshop report, the agenda, and the PowerPoint presentations are available below.

Documents

Report of the EMA/ETF workshop on Lessons Learned on Clinical Trials in Public Health Emergencies

Reference Number: EMA/340269/2023

Agenda - Lessons-learned workshop on Clinical Trials in Public Health Emergencies

Presentation - Setting the scene on the current regulatory framework (I. Clamou, European Commission)

Presentation - Role of the MS NCA, Ethics Committee, CT-CURE and ACT EU (G. Musch, K. Vanmolkot, S. Vanhiebecq)

Presentation - Role of EMA Emergency Task Force (M. Mura, EMA)

Presentation - Past-Experience MOSAIC, EU-RESPONSE (Y. Yazdanpanah, I.C. Olsen, P. Olliario (MOSAIC & EU-Solidact)

Presentation - Past-Experience STRIVE (J. Lundgren, University of Copenhagen)

Presentation - Current efforts for clinical research in preparedness and during emergencies in the EU (I. Norstedt, DG R&I)

Presentation - Current efforts for clinical research in preparedness and during emergencies in the EU (L. Muschel, European Commission)

Presentation - Pandemic Preparedness Partnership (H. Raoul, Be Ready)

Presentation - Coordination of trials (V. Simensen, J. Arne, NIPH)

Presentation - JAAM (J. Demotes, ECRIN)

Presentation - Experience from clinical trials MonkeyVax (L. Binh Luong)

Presentation - Experience from clinical trials VACCELERATE (O. Cornely)

Presentation - Experience from clinical trials EPOXI (M. Ekkelenkamp)

Presentation - European partnership on clinical trials initiative (H. Goossens, Belgian EU presidency)