Joint HMA/EMA Big Data Steering Group Workshop on RWE methods: Harnessing Real-World Data for Regulatory Use

Dates: 14 June, 2024

Status: scheduled (the event will take place as scheduled)

Mode: mixed (the event will take place both online and offline.)

The objectives of the workshop are:

  • To hear the views of stakeholders and experts:
    • on the draft RWE reflection paper open for public consultation in May
    • on priorities for further regulatory guidance development and collaboration beyond the reflection paper.
  • To engage with stakeholders on novel RWE methods in regulatory decision making.

Target Audience:

  • Internal: EMA staff and European Medicines Regulatory Network (EMRN)
  • External: Representatives from pharmaceutical industry, academia, regulatory bodies, health technology assessment (HTA), patients and healthcare professionals (HCP) by providing insights on use of RWE for regulatory decision making.


  • One day hybrid workshop (online and in person by invitation)


Friday, 14 June 2024, 09:00 – 16:30 CEST
Chaired by Peter Arlett (EMA, Head of Data Analytics and Methods Task Force (TDA), BDSG Co-chair) and Jeppe Larsen (Danish Medicines Agency, BDSG Co-chair)


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