))
A Guide to Marketing Authorisation Applications in Europe
Manage episode 441585909 series 3517729
Content provided by Boyds. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Boyds or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://ro.player.fm/legal.
In this episode, host Harriet Edwards is joined by Dr Katherine Bowen to explore the regulatory fundamentals for obtaining marketing authorisation in Europe, focusing on the centralised procedure. Together, they unpack the intricacies of this pathway, comparing it to the FDA application process and emphasising the critical role of thorough dossier preparation and clear communication with regulatory authorities. Key topics include the importance of early engagement with regulators, navigating the challenges of Module 1, developing risk management plans, and addressing current regulatory issues.
16 episoade
Distribuie
