From the end of this year, clinical trial sponsors of all shapes and sizes will be able to use the EU’s new centralized trial submissions portal and database. In view of the complexity of the system, practical training sessions as well as online informational materials will be on offer.
The European Medicines Agency is inviting clinical trial sponsors to take part in training programs on how to use the EU’s new centralized clinical trial submission and approval system, which is scheduled to go live at the end of this year.
The clinical trials information system (CTIS) will be a single EU entry point for submitting, assessing, authorizing, supervising and reporting...
<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>
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.
With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.
