HMA/EMA Task Force on Big Data

Introduction/Overview/Mandate

The mandate of the joint HMA/EMA Task Force on Big Data is to explore a number of issues regarding the emerging challenges presented by big data by:

  • Mapping relevant sources of big data and defining the main format in which they are expected to exist
  • Identifying the usability or application of big data
  • Describing the current state, future state and challenges with regard to;

    • regulatory expertise and competences
    • the need to specify legislation and guidelines
    • data analysing tools and sysytems needed to handle big data
    • regulators' responsibility for raw data analytics vs sponsor's responsibility

  • Designing a big data roadmap
  • Generating a list of recommendations as well as evaluating the usefulness of big data in the regultory setting
  • Collaborating with FDA, Health Canada and other third party country stakeholders, including ICMRA, to ensure bilateral insights on big data initiatives

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

Members and Representatives

The task force is composed of representatives from the NCAs in DE, DK, ES, FI, HU, IE, NL, NO, RO, UK and from EMA.

Chair: Thomas Senderovitz, DKMA, DK

Co-chair: Alison Cave, EMA

Contact

Secretariat:

Randi Munk-Jakobsen
 
Email: Bigdatasec@dkma.dk

Key Documents