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

- 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)This e-learning programme will familiarise you with the regulatory affairs principles involved in applying for a marketing authorisation in Europe (MRP, DCP, CP) . It will also introduce you to post-authorisation duties (renewal, variation...).LernzieleThis 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.ZielgruppenDo 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.