EMA Launches First RWE Studies Under Big Data Project
The European Medicines Agency has partnered with eight institutions having access to real-world healthcare data to enable its DARWIN EU project to deliver real-world evidence to the EU medicines regulatory network when needed.
You may also be interested in...
Without further work, the EU-wide joint clinical assessments introduced by the EU regulation on health technology assessments will fail to meet the needs of advanced therapies, warns the Alliance for Regenerative Medicine.
The EU’s big data steering group has laid out some ambitious proposals for integrating real-world evidence into regulatory decision making, as well as plans for ongoing engagement on the use and analysis of RWE with industry and other stakeholders.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty-eight documents have been posted on the tracker since its last update.