DDA7 – Serving Two Masters: Comparing and Contrasting US and EU Regulatory Submissions and Processes

Description

The purpose of this workshop is to introduce medical writers to the regulatory and cultural underpinnings of differing processes applied to the preparation, submission, review, and approval of regulatory submissions for pharmaceuticals to EU and US licensing authorities. On completion of the workshop, attendees should better understand the way the agencies operate and the requirements (as stated in the regulations and implicit in past practice) for preparing a successful dossier.

Participant profile: This workshop is intended for medical writers who wish to learn more about the global regulatory environment for pharmaceuticals.