Joint Heads of Medicines Agencies (HMA)/European Medicines Agency (EMA) Multistakeholder workshop on Patient Registries

• Date:
  Monday, 12 February 2024, All day
  Tuesday, 13 February 2024, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

Event summary

This joint two-day hybrid HMA/EMA workshop on Patient Registries follows on the successful disease-specific workshops held between 2017 and 2019, as well as the EMA multi-stakeholder workshop on qualification of novel methodologies.

The event will bring together representatives of registry holders, regulatory agencies, pharmaceutical companies, patients, healthcare professionals, academia, and health technology assessment bodies to address the following objectives:

• Day 1 - 12 February afternoon: Discuss the EMA qualification procedure for patient registries with the aim to clarify the benefits, identify current limitations, and propose measures to optimise the process;
• Day 2 - 13 February all day: Establish the value and enable the use of patient registries for regulatory decision-making by considering contexts of use for which registry data are ‘fit for purpose’, and examining tools to support data discoverability and assessment.

Documents

Report - Joint HMA/EMA multi-stakeholder workshop on Patient Registries

Agenda - Joint HMA/EMA multi-stakeholder workshop on Patient Registries

Adopted

Presentation - An agency of the European Union Scene setting on the EMA Qualification of novel methodologies (QoNM) for medicine development (A. Nolte)

Presentation - Main lessons learnt so far on the qualification of registries (J. Hillert, L. Nährlich)

Presentation - Outcomes of EFPIA survey on registries and qualification performed in February 2024 (G. Crane)

Presentation - Qualification of disease registries & PRAC (S. Straus)

Presentation - Opportunities for integration of the European Platform on Rare Disease Registration (EU RD Platform) with HMA/EMA catalogues (S. Martin)

Presentation - Investing to shape our future (C. Kyriakopoulou)

Presentation - What are the regulatory needs in terms of registry data? (B. Sepodes)

Presentation - EMA-funded registry-based study on spinal muscular atrophy disease (SMA) (K. Breen)

Presentation - Use case highlighting opportunities and challenges of registries for regulatory decision-making (S. Bennett)

Presentation - An agency of the European Union Fit for purpose and Data Quality Framework (K. Roes)

Presentation - HMA-EMA Catalogues of real-world data sources and studies (A. Cochino)

Presentation - Onboarding to EMA catalogue for RWD sources and studies: A user experience (F. Schaefer)

Presentation - Interoperability between registries and other data sources: the HARMONY Big Data Platform (J. María Hernández Rivas)

Video recording

Registration

In person participation is organised via EU associations and direct invitations to allow a broad range of stakeholders to participate. In person attendees will take part in face-to-face breakout sessions.

Virtual participation (in Webex) is possible upon registration by 12 January 2024:

• Register for this event

The Day 2 plenary sessions of the workshop will also be broadcast via the EMA corporate website. Registration is not required to follow the event online.

A video recording of the Day 2 plenary sessions will be available after the event.

Contact point

• [e-mail]