Call for expressions of interest to join DARWIN EU Advisory Board
HMA AND EMA are pleased to invite you to express your interest to joing the DARWIN EU Advisory Board
The mandate of the DARWIN EU advisory board includes one patient/consumer and one healthcare professional representative.
We hereby invite those interested to express interest, together with an outline of activities or experience you and/or your organisation has in the field of real world data & data analysis.
Please send your expressions of interest to us by 5th May 2021.
The Phase II report of the HMA-EMA joint Big Data Task Force outlines ten priority recommendations to evolve data-driven regulation, facilitating the development, authorisation and supervision of medicines.
The first of these recommendations is to put in place the capability to enable access to, and analysis of healthcare data from across the EU to support regulatory decision-making on medicines.
This capability is termed the Data Analysis and Real-World Interrogation Network – DARWIN EU. It will:
- Establish the DARWIN EU Coordination Center and related contractual services as well as connectivity to the European Health Data Space
- Conduct scientific studies to research questions supporting regulatory decision-making by the EMA scientific committees and the broader EU Medicines Regulatory Network;
- Maintain a catalogue of Real-World Data sources for use in the regulatory context and their metadata.
The focus of DARWIN EU will be on Real World Data (RWD)[1] including electronic health records and health insurance data (data from primary, secondary and/or hospital care).
Further information on the DARWIN EU regulatory use cases can be found in Annex I.
DARWIN EU Advisory Board
The mandate of the DARWIN EU Advisory Board was adopted by the Heads of Medicines Agencies and the EMA Management Board in March 2021 (attached). In brief, it will:
- Provide strategic advice and recommendations to the project team on the establishment of the DARWIN EU capability and its use of the European Health Data Space;
- Ensure continued coordination and alignment of the project with relevant European initiatives and policy as well as Member state initiatives; and
- Support two-way communication on DARWIN EU with the EU Regulatory Network, stakeholders and the European Health Data Space.
The Board will meet bi-monthly and we anticipate its meetings to last approximately 90-minutes. In addition, members will likely wish to prepare and may sometimes want to consult colleagues.
The first Advisory Board meeting is expected to take place in May 2021.
Kind regards,
Public and Stakeholders Engagement Department
Stakeholders and Communication Division
European Medicines Agency
[1] The RWD definition adopted by the EMA is 'routinely collected data relating to patient health status or the delivery of health care from a variety of sources other than traditional clinical trials'. This includes data from registries, claims, social media, M-health and electronic health records
