e-Learning: Introduction to EU Marketing Authorisation
Principles, Procedures, Application Types and Maintenance
- Up-to-date expert knowledge
- Flexibility in location and timing
- Compatibility with mobile devices
- Tests & certificate of completion (*)
- Officially certified to ISO 9001 and ISO 21001
e-Learning
From
390,00 €
plus VAT
Services & Process
Veranstaltung - 390,-€ zzgl. MwSt.
The fee for a single account that is valid for 90 days is €390 (excluding German VAT). You can access the modules as often as you want during this time. You will be awarded a certificate of completion at the end.
Booking details
e-Learning
From
390,00 €
plus VAT
Services & Process
Veranstaltung - 390,-€ zzgl. MwSt.
The fee for a single account that is valid for 90 days is €390 (excluding German VAT). You can access the modules as often as you want during this time. You will be awarded a certificate of completion at the end.
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...).
Your speaker
Dr. Christian M. Moers
Sträter Lawyers, Bonn, GERMANY
Lawyer;
His prime interests are the interdisciplinary challenges of medicinal product law. His focal advisory areas are as follows:
- European and German medicinal product…
Your speaker
Dr. Christian M. Moers
Sträter Lawyers, Bonn, GERMANY
Lawyer;
His prime interests are the interdisciplinary challenges of medicinal product law. 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
What to Expect
- 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)
Who Should Attend
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.
Objective of the Event
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.
Your Benefit
- Up-to-date expert knowledge & fl exibility in location and timing
- You will gain an overview of the law and EU regulatory network
- Get to know the differnt application types and post authorisation procedures
- Options to test your knowledge and personal certificate (*)
- All on an intuitive learning platform
(*)The certificate / learning assessments are generated based on an automated, non-individual multiple-choice test.
Programme
Dr. Christian M. Moers
- European Union law
- National law
- Soft law
- EU regulatory network
After having passed this module you can destinguish in between binding law and soft law and understand the principles of the European regulatory network.
Dr. Christian M. Moers
- Why marketing authorisations?
- The European Economic Area (EEA)
- What is a medicinal product?
- Scope of Directive 2001/83/EC
After having passed this module you understand the scope of Directive 2001/83/EC. You know under which conditions a product needs a marketing authorisation.
Dr. Christian M. Moers
- National ("one-member-state") procedure
- Mutual recognition procedure (MRP)
- Decentralised procedure (DCP)
- Referrals
- Centralised procedure (CP)
- Conditions
After having passed this module you understand the marketing authorisation pathways in the EU and know which product is eligable to which procedure.
Dr. Christian M. Moers
- Dossier
- Legal basis
- Generics
- Data exclusivity
- Homeopathic and herbal medicinal products
After having passed this module you understand the legal basis for each group of drugs and know which data has to be submitted to the authorities when applying for a marketing authorisation.
Dr. Christian M. Moers
- Renewals
- Sunset clause
- Variations
After having passed this module you know your duties in the drug lifecyle management and understand the variations system.
Module 1: Overview of the law and EU regulatory network
Module 1: Overview of the law and EU regulatory network
Dr. Christian M. Moers
- European Union law
- National law
- Soft law
- EU regulatory network
After having passed this module you can destinguish in between binding law and soft law and understand the principles of the European regulatory network.
Module 2: Principles
Module 2: Principles
Dr. Christian M. Moers
- Why marketing authorisations?
- The European Economic Area (EEA)
- What is a medicinal product?
- Scope of Directive 2001/83/EC
After having passed this module you understand the scope of Directive 2001/83/EC. You know under which conditions a product needs a marketing authorisation.
Module 3: Procedures
Module 3: Procedures
Dr. Christian M. Moers
- National ("one-member-state") procedure
- Mutual recognition procedure (MRP)
- Decentralised procedure (DCP)
- Referrals
- Centralised procedure (CP)
- Conditions
After having passed this module you understand the marketing authorisation pathways in the EU and know which product is eligable to which procedure.
Module 4: Application types
Module 4: Application types
Dr. Christian M. Moers
- Dossier
- Legal basis
- Generics
- Data exclusivity
- Homeopathic and herbal medicinal products
After having passed this module you understand the legal basis for each group of drugs and know which data has to be submitted to the authorities when applying for a marketing authorisation.
Module 5: Post authorisation
Module 5: Post authorisation
Dr. Christian M. Moers
- Renewals
- Sunset clause
- Variations
After having passed this module you know your duties in the drug lifecyle management and understand the variations system.
More options
For more information and registration simply click on this link: Regulatory Affairs Starter Pack
Downloads
Request the documents using our form.
Brochure
Weitere Informationen
Content
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.
How does it work?
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.
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Further Information
Your Contact Person
We are happy to advise you personally and individually.
Jean-Marie Bayhurst
Conference Manager
+49 6221 500-685
j.bayhurst@forum-institut.de