A Guide to Marketing Authorisation Applications in Europe

Conversations in Drug Development

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.