EMA Launches First RWE Studies Under Big Data Project
Executive Summary
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...
Direction Of Travel Of EU HTA Regulation Is ‘Disappointing’ For Advanced Therapies
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.
RWE Studies To Hit 100+ Per Year In Europe By 2025
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.
Global Pharma Guidance Tracker – March 2024
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.