Joint HMA/EMA multi-stakeholder workshop on Patient Registries

We are honored to contribute to the Joint Heads of Medicines Agencies (HMA)/European Medicines Agency (EMA) Multistakeholder workshop on Patient Registries, organized on 12 and 13 February in Amsterdam, the Netherlands.

---

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 the qualification of novel methodologies. The EMA workshop 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.

---

On behalf of the HARMONY Alliance, Jesús María Hernández Rivas (Institute of Biomedical Research of Salamanca, IBSAL), will participate in Session 2: "Experience gained, and lessons learnt from initiatives aiming to leverage the use of registries". Dr. Hernández Rivas will talk about the Interoperability between registries and other data sources, such as the HARMONY Big Data Platform.

The HARMONY Alliance would like to thank EHA, the European Hematology Association for this opportunity.

---

Click here for more information about the EMA workshop >

Clich here to view the agenda >

---

---

Receive the latest news. Click here to subscribe!