Insights from the EMA Big Data Steering Group Workshop
We are thrilled to share that Jasmina Savic, our Managing Director at Phortas, recently participated in the European Medicines Agency (EMA) workshop held in Amsterdam, Netherlands.
This one-day hybrid Big Data Steering Group (BDSG) workshop convened representatives from regulatory agencies, pharmaceutical companies, patients, healthcare professionals, academia, and health technology assessment bodies.
Workshop Objectives
The BDSG workshop aimed to address several key objectives:
Gathering Stakeholder and Expert Opinions:
Discussions centered around the draft real-world evidence (RWE) reflection paper.
Prioritizing further regulatory guidance development and fostering collaboration beyond the reflection paper.
Engaging Stakeholders on RWE Methods:
Examining the integration of RWE methods in regulatory decision-making processes.
Key Takeaways
Participating in direct discussions with EMA, Heads of Medicines Agencies (HMA), industry representatives, associations, and patients was a valuable experience.
The focus was on the potential of Real World Evidence (RWE) data in enhancing regulatory decisions, particularly in accepting studies using RWE data in post-approval setting, as well as accepting RWE data for pre-approval studies that will be part of the future marketing authorizations.
A significant next step from the workshop is the establishment of the HMA EMA RWE catalogues, which will serve as a comprehensive resource for real-world data sources and studies. More information on these catalogues can be found on the HMA-EMA Catalogues of real-world data sources and studies homepage.
Conclusion
Our involvement in this workshop underscores our commitment to staying at the forefront of regulatory developments and contributing to the evolving landscape of pharmaceutical regulation, especially in paving the path for use of RWE data in drug development. We look forward to continuing our engagement with stakeholders and experts in the field to further the use of real-world evidence in regulatory decision-making.
Stay tuned for more updates on our participation in such pivotal events and our ongoing efforts to enhance regulatory processes through innovative approaches.
Contact us at info@phortas.com to explore how Phortas can support you with RWE projects.
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