The EU recommendation paper on decentralized clinical trials (DCTs) marked an important “first step” on the direction the European regulatory network wants to take with DCTs. Member states are now focused on reviewing and tracking DCTs to gain experience before considering the need for any updates to the recommendation paper.
Six months after the European medicines regulatory network issued harmonized recommendations on conducting decentralized clinical trials (DCTs), EU member states are focused on implementing these perspectives in their national environments.
The pan-EU DCT recommendation paper will form the basis for “best practices” for authorizing and inspecting clinical trials in Europe,...
<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.
