EMA/HMA – Joint HMA/EMA Big Data Steering Group workshop on real-world evidence (RWE) methods: Event materials now available

The EMA published all the presentation materials and the video recording of the Joint HMA/EMA Big Data Steering Group workshop on real-world evidence (RWE) methods.

This one-day hybrid Big Data Steering Group (BDSG) workshop brings together representatives of regulatory agencies, pharmaceutical companies, patients, healthcare professionals, academia, and health technology assessment bodies to address the following objectives:

• Hear the views of stakeholders and experts:
  • on the draft real-world evidence (RWE) reflection paper,
  • on priorities for further regulatory guidance development and collaboration beyond the reflection paper.
• Engage with stakeholders on RWE methods in regulatory decision making.

More information on this meeting EMA Website and more information on the Joint HMA/EMA Big Data Steering Group on the HMA and EMA Websites.