2026-03-14 2026-03-14 , 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.

Topics
  • 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.
Aims and objectives
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.
Your benefit

  • 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

JETZT Buchen

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
List of Abbreviations Pharmacovigilance PROSPEKT
List of Abbreviations Pharmacovigilance PROSPEKT
Gebühr

Event - 990€ plus tax

Event - 990€ plus tax

Inhouse-Angebote
Inhouse-Angebot anfordern
Inhouse-Angebot anfordern

Jetzt buchen

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.

Topics

  • 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.

Aims and objectives

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.

Your benefit

  • 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.

FAQ

How is the course structured?

The self-learning course consists of three e-learning modules covering the following key topics: EU marketing authorisation procedures, the variation system and the Common Technical Document (CTD). The e-learnings primarily include videos, audio content, texts, interactive exercises, and knowledge checks.

How does it work?

  1. You book the course on our website.
  2. You will receive an email with your login details for our customer portal and will be forwarded from there to the learning platform.
  3. You start your e-learning modules at your own pace and at any time that suits you.
  4. You complete each module with a short knowledge check.
  5. After successfully completing each module, you will receive a certificate as proof of completion.
Try the free demo version of our e-learning modules and get a first impression of our learning environment.

Other Options:

You prefer to ask questions directly and connect with other participants? Then we recommend our introductory live online seminars. You can find an overview here: https://www.forum-institut.com/area/2620-regulatory-affairs-vigilance Or get in touch with us directly for a personal consultation.

e-Learning: Introduction to EU Marketing Authorisation

This e-learning programme will familiarise you with the regulatory affairs principles involved in applying for a marketi...

jederzeit
Details

e-Learning: EU Variation System and Procedures

This e-Learning programme will provide you with detailed knowledge on the classification, grouping and submission of var...

jederzeit
Details

e-Learning: Common Technical Document and eCTD

Do you need know how regarding CTD/eCTD & CMC? Then this e-learning programme is the fast track to becoming knowledgeabl...

jederzeit
Details