EU drug regulators have created a new task force to establish a roadmap and recommendations on how to use big data in the assessment of medicines.
The European Medicines Agency, along with the heads of national competent authorities in the EU, has formed a new task force to establish a roadmap and issue recommendations on how drug regulators can use big data to “support research, innovation and robust medicines development”.
The task force, which is being chaired by the Danish Medicines Agency and co-chaired by the EMA, will look at,...
<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.
