2026-03-21 2026-03-21 , online online, 390 € zzgl. MwSt. 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...).

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)


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.
Ziel der Veranstaltung
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.
Teilnehmerkreis

  • 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.

e-Learning: Introduction to EU Marketing Authorisation

e-Learning: Introduction to EU Marketing Authorisation

Principles, Procedures, Application Types and Maintenance

Benefits
  • 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

Webcode 26122644

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Alles auf einen Blick

Termin

anytime

anytime

Zeitraum

Veranstaltungsort

online

online

Downloads
PROSPEKT
PROSPEKT
Gebühr

Event - 390€ plus tax
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.

Event - 390€ plus tax
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.

Inhouse-Angebote
Inhouse-Angebot anfordern
Inhouse-Angebot anfordern

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Your contact

Jean-Marie Bayhurst
Conference Manager

+49 6221 500-685
j.bayhurst@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...).

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)


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.

Ziel der Veranstaltung

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.

Teilnehmerkreis

  • 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.