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 distinguishes our event
Aims and objectivesThis 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 developed in May 2018.
- European Union law
- National law
- Soft law
- EU regulatory network
- Why marketing authorisations?
- The European Economic Area (EEA)
- What is a medicinal product?
- Scope of Directive 2001/83/EC
- National ("one-member-state") procedure
- Mutual recognition procedure (MRP)
- Decentralised procedure (DCP)
- Centralised procedure (CP)
- Legal basis
- Data exclusivity
- Homeopathic and herbal medicinal products
- Sunset clause
Lawyer; His prime interests are the interdisciplinary challenges of medicinal product law as presented, for example, in the new GDP guidelines, the ATMPs and in data protection and electronic data communication. His focal advisory areas are as follows: European and German medicinal product law, marketing authorisation law & regulatory affairs, pharmacovigilance; wholesale trade with medicinal products, distribution of medicinal products, manufacture of medicinal products
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The e-learning programme 'Introduction to EU Marketing Authorisation' comprises five didactic modules that include videos in which the expert Dr Christian Moers shares his expertise with you. You can also download and print the corresponding presentation documents.
Each module comprises additional documents (links, guideline texts, etc.) as well as interactive exercises and questions, which help you practise and apply your newly gained knowledge.
Once you have completed the five modules and passed a final multiple-choice test, you will be awarded a certificate, which you can print out directly. The e-learning programme should be completed within three months. Try our e-learning programme for free and familiarise yourself with our learning environment.
1. Register for an e-learning programme on our website.
2. You will receive an email with your login data for our learning platform.
3. Log in to start your e-learning programme.
4. Complete your e-learning modules at your own pace.
5. Finalise the modules with a multiple-choice test.
6. Once you have successfully completed the test, you will be awarded a certificate, which you can print out.
Please try out the demo versions of our e-learning programmes free of charge to get an idea of our learning environment.