A month after EU regulators created a task force to work out how to use big data to support drug evaluation, Thomas Senderovitz, the head of the Danish Medicines Agency who chairs the new group, tells the Pink Sheet’s Vibha Sharma what to expect from the initiative.
The task force that EU regulators set up just over a month ago to explore how “big data” might be used to improve drug development and regulation has now met twice and has established a clear plan for the work ahead.
The big data task force is a joint initiative by the European Medicines Agency and the EU Heads...
<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.
