EMA multi-stakeholder workshop on psychedelics – Towards an EU regulatory framework

• Date:
  Tuesday, 16 April 2024 , 13:00 - 18:00 Amsterdam time (CEST)
  Wednesday, 17 April 2024 , 09:30 - 16:00 Amsterdam time (CEST)
• Location:
  Online
  European Medicines Agency, Amsterdam, the Netherlands
  Live broadcast

Event summary

This multi-stakeholder workshop brings together patients, healthcare professionals, academia, regulators, and industry to discuss the development and therapeutic use of psychedelic substances to address unmet medical needs in the area of mental health. 

The aims of the workshop are to:

• Hear the views of stakeholders and experts on the therapeutic potential of psychedelics; 
• Provide further clarity on defining the safe and effective use of psychedelics;
• Inform on regulatory challenges associated with the development and evaluation of psychedelic medicines;
• Define areas for which further regulatory guidance is required.

Documents

Report - EMA multi-stakeholder workshop on psychedelics

Agenda - EMA multi-stakeholder workshop on psychedelics – Towards an EU regulatory framework

Presentation - Clinical development of psychedelics for psychiatric disorders (N. Hefting, G. Goodwin)

Presentation - European regulatory perspective of psychedelic drugs in psychiatry (M. Haberkamp)

Presentation - Australian regulatory perspective of psychedelic drugs in psychiatry (R Langham)

Presentation - American regulatory perspective of psychedelic drugs in psychiatry (M. Sokolowska)

Presentation - Legal status of psychedelics and impact in research and development (T. Hawrot)

Presentation - Challenges with Health technology assessment after approval (C. Martín Saborido)

Presentation - National experience with medical use of psychedelics (J. Horacek)

Presentation - Identification of methodological issues and how to overcome them (G. Knudsen)

Presentation - Drawing from ongoing trials and existing clinical experience (E. Bałkowiec-Iskra)

Presentation - Set and setting research potential implications for future approval (M. Beckman)

Presentation - Psychedelic treatments; questions from research and clinical implementation (R. Schoevers)

Presentation - Clinical experience learned from approved esketamine and potential implications for psychedelics (P. Gorwood)

Presentation - What can patient and public involvement in research contribute to safe and effective use (I. Dziobek)

Video recordings