HMA/EMA Joint Big Data Steering Group

Introduction/Overview/Mandate

The HMA/EMA joint Big Data Steering Group supersedes the Big Data Task Force and covers the following tasks:

  1. Making proposals to HMA and EMA MB for the prioritisation and planning of actions to implement the recommendations from the Task Force report.
    - Oversee those actions that the Network decides to run.
    - Monitor other relevant actions that are not run at Network level.
    - Maintain an inventory of ongoing EU Regulatory Network projects relevant to Big Data.
  2. On request, providing input on strategic planning including the Network Strategy to 2025 and the EMA multi-annual workplan.
  3. Making proposals to HMA and EMA MB for the definition and measurement success factors.
  4. Supporting communication on Big Data to the Network and its stakeholders.
  5. Monitoring for reports and publications on data analytics and tools relevant to advances in the science, technology, legislation, and regulation of Big Data to identify opportunities and threats and make recommendations to HMA and EMA MB.
  6. Identifying product applications relevant to Big Data, not fully regulated by the current EU framework.
  7. Ensuring coordination and alignment towards goals with the Commission services (including flagship policy initiatives such as Europe’s Beating Cancer Plan and the European Health Data Space), HMA and EMA on any ongoing or new initiatives.
  8. Identifying funding opportunities relevant to the priority recommendations on Big Data.
  9. Ensuring that the perspectives of patients, pet and livestock owners and healthcare professionals are considered when making recommendations.

HMA-EMA joint Big Data Steering Group: Mandate | pdf

Task force to establish roadmap and recommendations for use of big data in assessment of medicines | EMA News Release

Role of big data for evaluation and supervision of medicines in the EU | EMA News Release 15 February 2019

Members and Representatives

The steering group is composed of representatives from the NCAs (7 - hum + vet), EC, eHealth Network (1), EU-IN (1), EU Network Telematics governance (1), CHMP (1), PRAC (1), SAWP (1), CVMP (1), EU Patient associations (1), EU HCP associations (2) and EMA (3 – IT, analytics, communications).

The task force is co-chaired by the HMA and EMA representatives:

  • Co-chair: Nikolai Brun, DKMA, DK
  • Co-chair: Peter Arlett, EMA

HMA-EMA joint Big Data Steering Group: membership list | pdf

Contact

EMA Secretariat:

Jolanta Palepsaitiene
 
Email: Jolanta.PalepsaitienenoSpam@noSpamema.europanoSpam.eu

Key Documents

  • HMA/EMA Joint Big Data Steering Group Workplan 2022-2025 | pdf
  • HMA/EMA Joint Big Data Steering Group 2022 report | pdf
  • HMA/EMA Joint Big Data Steering Group 2021 report | pdf
  • HMA/EMA Joint Big Data Steering Group 2020 report | pdf
  • HMA/EMA Joint Big Data Steering Group workplan | pdf
    Document adopted on 27 July 2020

Phase I

  • HMA/EMA Joint Task Force on Big Data - Annex IV Survey for Pharmaceutical Industry | pdf
  • HMA/EMA Joint Task Force on Big Data - Annex IV Survey for National Competent Authorities | pdf
  • HMA/EMA Joint Task Force on Big Data - Annex V Survey results | pdf
  • HMA/EMA Joint Task Force on Big Data - Summary report | pdf

Task Force subgroups reports from Phase I

  • Clinical Trial and Imaging Subgroup | pdf
  • Observational data subgroup | pdf
  • Genomics subgroup | pdf
  • Spontaneous ADR subgroup | pdf
  • Data analytics subgroup | pdf
  • Bioanalytical Omics subgroup | pdf
  • Social media/M-health data subgroup | pdf
  • Survey design and analysis | pdf

Phase II

  • HMA/EMA Joint Task Force on Big Data - Phase II report Evolving Data Driven Regulation | pdf
  • Priority recommendations of the HMA/EMA joint Big Data Task Force | pdf

Data standardisation strategy

The European medicines regulatory network's data standardisation strategy sets out principles to guide the definition, adoption and implementation of international data standards by the network.

It aims to:

  • enable quicker uptake of international data standards across the EU;
  • improve data quality;
  • enable data linkage and data analysis to support medicine regulation.
  • The strategy is a key deliverable of the Big Data Steering Group workplan.

EMA and HMA published the strategy in December 2021 and will maintain it over time to reflect any changing priorities or new requirements.

European Medicines Regulatory Network Data Standardisation Strategy