A restructuring involving the setting up of four new task forces is aimed at improving how the European Medicines Agency responds to issues such as permanent staff reductions and challenges in regulatory science, digital business transformation, and clinical trial strategy.
The European Medicines Agency is to embark on a “future-proofing” exercise that will involve restructuring its operations to allow it to respond more effectively to a “permanently reduced headcount” and to new challenges in science, technology and legislation.
The new structure was presented at the December meeting of the EMA’s management board. It will include the setting up...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
