2022-05-22 2022-05-22 , online online, 390,- € plus tax Dr. Christian M. Moers https://www.forum-institut.com/seminar/22122044-e-learning-introduction-to-eu-marketing-authorisation/referenten/22/22_12/22122044-e-learning-introduction-to-eu-marketing-authorisation_moers-christian-m.jpg e-Learning: Introduction to EU Marketing Authorisation

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...).

Topics
  • 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)
Aims and objectives
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 developed in May 2018 and revised in 2020.
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.

e-Learning: Introduction to EU Marketing Authorisation

Introduction to EU Marketing Authorisation

e-Learning

Benefits
  • Up-to-date expert knowledge
  • Flexibility in location and timing
  • You establish your own learning speed
  • Tests and feedback
  • Certificate of completion
  • Compatibility with mobile devices

Webcode 22122044

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JETZT Buchen

Speaker


Everything at a glance

Appointment

anytime

anytime

Period

Venue

online

online

Fee
Your contact person

Dr. Henriette Wolf-Klein
Head of Department

+49 6221 500-680
h.wolf-klein@forum-institut.de

Details

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...).

Topics
  • 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)
Aims and objectives

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 developed in May 2018 and revised in 2020.

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.

Program

Module 1: Overview of the law and EU regulatory network
  • 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
  • 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
  • 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
  • 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
  • Renewals
  • Sunset clause
  • Variations
After having passed this module you know your duties in the drug lifecyle management and understand the variations system.

Trailer

e-Learning: Introduction to EU Marketing Authorisation

Here you can get a brief insight into the e-Learning Introduction to EU Marketing Authorisation.

Principles

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.

This distinguishes our events

Modules

Hour access to your personal learning environment on every day

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