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.
EU regulators say they expect four real-world evidence (RWE) studies to be initiated with 10 data partners through the RWE network, DARWIN, by the fourth quarter of this year, with the number of EU studies rising to more than 100 each year by the beginning of 2025.
Also in the works are the publication of a good practice guide on real-world metadata, the development of analytics tools...
<p>Executive Summary</p> <p>A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.</p>
As the reform of the EU pharmaceutical legislation progresses through the legislative process, the Pinks Sheet offers an infographic highlighting some of the key changes being proposed that will reshape the way drug companies run their business.
<p>Executive Summary<p> <p>The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add six new products, incl/ding Ixchiq, Valneva's chikungunya virus vaccine</p>
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.
