Joint EC/HMA/EMA multi-stakeholder workshop on pharmacogenomics

• Date:
  Tuesday, 24 September 2024 , 09:00 - 17:00 Amsterdam time (CEST)
• Location:
  Online
  European Medicines Agency, Amsterdam, the Netherlands
  Live broadcast

Event summary

The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) are organising a multi-stakeholder hybrid workshop on Pharmacogenomics at EMA in Amsterdam.

The objectives of the workshop are to:

• identify priority areas for additional regulatory action to promote the clinical implementation of pharmacogenomics;
• discuss how medicines regulators can facilitate the uptake of genomics by national healthcare systems;
• discuss how to leverage genomic data linked to real-world data sources with examples of current studies using such data;
• discuss how to increase the regulatory impact of EU-funded projects in personalised medicine.

The outcome of the workshop will inform a roadmap towards the clinical implementation of pharmacogenomics in Europe.

Virtual participation to the event is open to all stakeholders. Prior registration will be required. In-person participation will be confirmed by invitation only.

The event will be broadcast and recorded, and the recording will be made available on the EMA event page a few weeks after the event.

Registration

Registration is closed

Documents

Report - Joint EC/HMA/EMA multi-stakeholder workshop on pharmacogenomics (24 September 2024)

Agenda - Joint EC/HMA/EMA multi-stakeholder workshop on pharmacogenomics (24 September 2024)

Adopted

Presentation - Why pharmacogenomics is important for public health (M. Jesús Lamas, AEMPS)

Presentation - Current state of the art in pharmacogenomics - a regulatory perspective (M. Maliepaard, MEB)

Presentation - Overview of medicinal products with pharmacogenomics information in the SmPC (M. Gordillo-Marañón, AEMPS, UCL)

Presentation - Pharmacogenetics implementation in Spain (A. Llerena, INUBE)

Presentation - Pharmacogenetics implementation in the UK (M. Pirmohamed, D. Weatherall, University of Liverpool)

Presentation - Pharmacogenetic testing in Belgium (KCE)

Presentation - Pharmacogenomics implementation in Germany (C. Scholl, BfArM)

Presentation - Pharmacogenomics, an update (M. Ingelman-Sundberg, Karolinska Institutet)

Presentation - Consideration on data sources and data types (S. Reisberg, University of Tartu)

Presentation - Pharmacogenomics in real-world data studies (D. Prieto-Alhambra, J. Xie, University of Oxford)

Presentation - HMA-EMA Catalogues of real-world data sources and studies (S. Simou, EMA)

Video recording