Qualification Course: EU Regulatory Affairs Manager

Die Themen

- Regulatory frameworks, application types, and procedures - Mutual recognition, decentralised, and centralised procedures (MRP, DCP, CP) in detail - Marketing authorisation dossier and the electronic submission process - CTD structure and modules 1-5 in detail - Regulatory lifecycle management, variation submission, PV activities, and labelling changes

Ziele

This qualification course provides an in-depth exploration of EU drug regulatory affairs. With two e-learnings for self-study and three live online seminars led by regulatory affairs experts, participants will acquire comprehensive knowledge and practical strategies for successful marketing authorisation applications and lifecycle management in the EU.

- The two e-learnings cover the basics of marketing authorisation in the EU and the variations system, allowing participants to build a solid foundation through self-study.

- Three live online seminars cover the topics of marketing authorisation procedures, the common technical document (CTD), and lifecycle management. Regulatory affairs experts provide practical knowledge, essential insights, and strategies for regulatory affairs management in the EU. Examples and case studies, as well as time for questions, are included.

Wer sollte teilnehmen?

This qualification course is specifically tailored for beginners and career changers who wish to start a career in EU drug regulatory affairs.

- Junior regulatory affairs managers who need in-depth knowledge about the main regulatory duties, from marketing authorisation applications to lifecycle management, will also benefit from the course.