2026-03-21 2026-03-21 , online online, 990 € zzgl. MwSt. Regulatory Affairs Starter Pack

Three e-Learning programmes in one bundle: Get a solid foundation in EU marketing authorisation procedures, the EU variation system and the Common Technical Document (eCTD). Your fast track into EU Regulatory Affairs - at a special bundle price.

Themen
  • e-Learning 1: Introduction to EU Marketing Authorisation: Regulatory affairs principles, procedures, application types and maintenance
  • e-Learning 2: EU Variation System & Procedures: Lifecycle management, variation classification, grouping, worksharing & submission
  • e-Learning 3: Common Technical Document & eCTD: CTD structure, format and content, validation, CMC data


Who should attend
  • Professionals and career changers entering the field of Regulatory Affairs with no or limited prior experience.
  • Colleagues from adjacent functions (Quality Assurance, Medical Affairs, CMC, Pharmacovigilance, Market Access, Business Development...) who need a working knowledge of EU regulatory procedures.
  • Companies onboarding new team members in Regulatory Affairs.

No prior regulatory experience is required.
Ziel der Veranstaltung
This self-learning course gives you a practical introduction to the three essentials of EU Regulatory Affairs: marketing authorisation procedures, the variation system and the eCTD. Upon completion, you will have a solid understanding of:
  • How marketing authorisations are obtained and maintained in the EU
  • How to classify, prepare and submit variations
  • How regulatory dossiers are structured and submitted

The bundle is designed as a self-contained learning path. You will receive access to our learning platform and can work through all 3 e-Learnings within 90 days.

  • Your time investment: ~ 1,5 working days in total.
  • Your learning units: Flexible sessions from 10 minutes to half a day - you set the pace.
  • Your benefit: A solid foundation in EU Regulatory Affairs - ready to apply from day one.
Teilnehmerkreis

  • 3 e-Learnings, 1 price - save over 30% compared to individual bookings
  • Structured learning path & flexibility - 90 days access, learn at your own pace, anytime, anywhere
  • Tests & certificates of completion for each module (*)

(*)The certificate / learning assessments are generated based on an automated, non-individual multiple-choice test.

Regulatory Affairs Starter Pack

Regulatory Affairs Starter Pack

Your fast track into EU Regulatory Affairs - self-paced & flexible

Benefits
  • Structured learning path
  • Flexible learning units & knowledge checks
  • 3 e-learnings, 1 price - save over 30%
  • Officially certified according to ISO 9001 and 21001

Webcode 60012640

Jetzt buchen

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Alles auf einen Blick

Termin

01/01 - 31/12/2026

01/01 - 31/12/2026

Zeitraum

Start is possible anytime. You will have access to all content for 90 days from the booking date. You can access the modules as often as you want during this time.

Start is possible anytime. You will have access to all content for 90 days from the booking date. You can access the modules as often as you want during this time.
Veranstaltungsort

online

online

Downloads
PROSPEKT
PROSPEKT
Gebühr

Event - 990€ plus tax

Event - 990€ plus tax

Inhouse-Angebote
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Inhouse-Angebot anfordern

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Your contact

Jean-Marie Bayhurst
Conference Manager

+49 6221 500-685
j.bayhurst@forum-institut.de

Details

Three e-Learning programmes in one bundle: Get a solid foundation in EU marketing authorisation procedures, the EU variation system and the Common Technical Document (eCTD). Your fast track into EU Regulatory Affairs - at a special bundle price.

Themen

  • e-Learning 1: Introduction to EU Marketing Authorisation: Regulatory affairs principles, procedures, application types and maintenance
  • e-Learning 2: EU Variation System & Procedures: Lifecycle management, variation classification, grouping, worksharing & submission
  • e-Learning 3: Common Technical Document & eCTD: CTD structure, format and content, validation, CMC data


Who should attend
  • Professionals and career changers entering the field of Regulatory Affairs with no or limited prior experience.
  • Colleagues from adjacent functions (Quality Assurance, Medical Affairs, CMC, Pharmacovigilance, Market Access, Business Development...) who need a working knowledge of EU regulatory procedures.
  • Companies onboarding new team members in Regulatory Affairs.

No prior regulatory experience is required.

Ziel der Veranstaltung

This self-learning course gives you a practical introduction to the three essentials of EU Regulatory Affairs: marketing authorisation procedures, the variation system and the eCTD. Upon completion, you will have a solid understanding of:

  • How marketing authorisations are obtained and maintained in the EU
  • How to classify, prepare and submit variations
  • How regulatory dossiers are structured and submitted

The bundle is designed as a self-contained learning path. You will receive access to our learning platform and can work through all 3 e-Learnings within 90 days.

  • Your time investment: ~ 1,5 working days in total.
  • Your learning units: Flexible sessions from 10 minutes to half a day - you set the pace.
  • Your benefit: A solid foundation in EU Regulatory Affairs - ready to apply from day one.

Teilnehmerkreis

  • 3 e-Learnings, 1 price - save over 30% compared to individual bookings
  • Structured learning path & flexibility - 90 days access, learn at your own pace, anytime, anywhere
  • Tests & certificates of completion for each module (*)

(*)The certificate / learning assessments are generated based on an automated, non-individual multiple-choice test.