EMA to reinstate its proactive clinical data publication policy

Elizabeth Anne Wright

EMA has decided to restart implementation of its policy to proactively publish clinical data.

REACH for the stars!

Emma Bichet, Carol Holley and Selma Abdel-Qader

Cooley’s Productwise Bitesize brings you a short introduction to the REACH Regulation.

New EU rules on the design and production of batteries published

Ed Turtle, Tracey Bischofberger and Selma Abdel-Qader

After lengthy negotiations, the ‘final’ text of the EU Batteries Regulation agreed between the European Commission, Parliament and Council has been published. Whilst it’s possible there could still be minor changes, you can expect this to be substantively the same as the final published legislation.

The EMA publishes updated Q&A on clinical trial sponsor oversight of delegated tasks

Elizabeth Anne Wright

Read a summary of EMA’s updated guidance on how clinical trial sponsors can demonstrate oversight of activities delegated to third party service providers.

European Commission publishes updated Q&A on the Clinical Trials Regulation

Jessica Lauren Koffel

Read a summary of the updated version of the Q&A guidance on the Clinical Trials Regulation.