e-Learning: Introduction to EU Marketing Authorisation - Principles, Procedures, Application Types and Maintenance

Die Themen

- Module 1: Overview of the law and EU regulatory network - Module 2: Principles (The European Economic Area & the scope of Directive 2001/83/EC) - Module 3: Procedures (MRP, DCP, CP, Referrals) - Module 4: Application types (legal basis, CTD requirements, Generics, Herbals) - Module 5: Post authorisation (Renewals, Sunset Clause, Variations)

Ziele

This e-Learning programme will familiarise you with the regulatory affairs principles involved in applying for a marketing authorisation in Europe. It addresses the EU marketing authorisation procedures for the various products. It will also introduce you to post-authorisation duties.

- Upon completion, you will be conversant with the key principles of regulatory affairs and have a good starting basis to work in this field.

- This e-Learning was revised in 2025.

Wer sollte teilnehmen?

Do you need basic regulatory affairs expertise since you already work in the pharmaceutical industry or plan to start working in this field? Then this e-Learning programme is the fast track to becoming knowledgeable in this field. No prior regulatory experience is required.