2025-12-23 2025-12-23 , online online, 220 € zzgl. MwSt. Qualification Course Regulatory Affairs Manager

With our modular qualification course, you can expand your competencies in drug regulatory affairs in a targeted and practice-oriented manner. You design your learning pathway individually and set professional focus areas in line with your occupational requirements. Including an overall certificate and up to 30% price advantage compared with individual bookings.

Topics
  • EU pharmaceutical law and regulatory framework
  • Marketing authorisation procedures
  • Application types and regulatory strategies
  • Submission planning and dossier management
  • Post-authorisation activities, including renewals and variations
  • Optional deep dives into global regulatory regions, such as GCC, EAEU and LATAM


Who should attend
The course is aimed at specialists and managers in the pharmaceutical industry as well as service providers who wish to build or deepen their knowledge in regulatory affairs.

It is also suitable for professionals seeking a structured entry into this specialised field. Career starters will benefit from gaining a clear understanding of regulatory principles and processes, supporting a successful start in regulatory affairs and related functions.
Aims and objectives
This qualification course is designed for professionals who wish to obtain a sound and structured qualification in regulatory affairs within the pharmaceutical industry, while remaining flexible and able to set individual thematic priorities. The programme combines guided self-study with interactive live online seminars, enabling participants to develop a solid understanding of regulatory requirements for human medicinal products. Core principles of marketing authorisation in Europe are covered as a foundation, with the opportunity to deepen knowledge through selected additional online trainings.
Your benefit

  • Flexible completion within a few weeks or up to 18 months
  • Structured learning path with modular content selection
  • Practical understanding of EU marketing authorisation principles
  • Opportunity to deepen knowledge in European or global regulatory affairs

Qualification-Course-Regulatory-Affairs

Qualification Course
Regulatory Affairs Manager

Benefits
  • You gain a comprehensive foundation in RA
  • You strengthen your professional qualifications.
  • You choose individual focus areas.
  • You save up to 30% compared with individual bookings.

Webcode 60012501

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Termin

01/01 - 31/12/2026

01/01 - 31/12/2026

Zeitraum

A duration of a few weeks up to a maximum of 18 months, depending on the selected modules.

A duration of a few weeks up to a maximum of 18 months, depending on the selected modules.
Veranstaltungsort

online

online

Gebühr
Your contact

Verena Planitz
Conference Manager

+49 6221 500-655
v.planitz@forum-institut.de

Details

With our modular qualification course, you can expand your competencies in drug regulatory affairs in a targeted and practice-oriented manner. You design your learning pathway individually and set professional focus areas in line with your occupational requirements. Including an overall certificate and up to 30% price advantage compared with individual bookings.

Topics

  • EU pharmaceutical law and regulatory framework
  • Marketing authorisation procedures
  • Application types and regulatory strategies
  • Submission planning and dossier management
  • Post-authorisation activities, including renewals and variations
  • Optional deep dives into global regulatory regions, such as GCC, EAEU and LATAM


Who should attend
The course is aimed at specialists and managers in the pharmaceutical industry as well as service providers who wish to build or deepen their knowledge in regulatory affairs.

It is also suitable for professionals seeking a structured entry into this specialised field. Career starters will benefit from gaining a clear understanding of regulatory principles and processes, supporting a successful start in regulatory affairs and related functions.

Aims and objectives

This qualification course is designed for professionals who wish to obtain a sound and structured qualification in regulatory affairs within the pharmaceutical industry, while remaining flexible and able to set individual thematic priorities. The programme combines guided self-study with interactive live online seminars, enabling participants to develop a solid understanding of regulatory requirements for human medicinal products. Core principles of marketing authorisation in Europe are covered as a foundation, with the opportunity to deepen knowledge through selected additional online trainings.

Your benefit

  • Flexible completion within a few weeks or up to 18 months
  • Structured learning path with modular content selection
  • Practical understanding of EU marketing authorisation principles
  • Opportunity to deepen knowledge in European or global regulatory affairs

FAQ

Concept

The qualification course is structured around one base module and a minimum of two elective online training modules, allowing for a flexible and well-balanced learning experience.

1. e-learning (self-study): "Introduction to EU marketing authorisation"
Aim: To develop a solid foundational understanding of regulatory affairs for medicinal products within the European Union.

2. Elective modules (online seminars): individual focus areas
Aim: To enable targeted professional specialisation within regulatory affairs. Participants select at least two online training modules from a range of available options, which may differ in scope and duration. Additional e-learning courses can also be booked as part of the qualification course; however, these do not count as online training modules and are not included in the mandatory module requirements.

Upon successful completion of all required modules, participants receive the certificate "Qualification Course Regulatory Affairs Manager".

Training duration

The overall scope of the programme varies depending on your individual choice of modules and comprises at least three working days. You will find the exact duration of each course in the respective module descriptions. You have up to 18 months to complete the full programme, although you are also welcome to finish it within a few weeks, entirely according to your schedule.

Individual booking and guidance

We will be happy to advise you personally on your booking options.

v.planitz@forum-institut.de
+49 6221 500-655

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

Your plans change during the programme?

No problem. Up to 14 days before the respective seminar module, you may reschedule to a different date or switch to another seminar, subject to a processing fee of €50 plus statutory VAT.

Technical requirements

You need a reliable Internet connection to take part in our online events. To have the best possible learning experience, we recommend that you use the latest version of the Microsoft Edge or Google Chrome browsers. You will need a headset, loudspeaker or telephone to play the audio. Further information is available here. Please check beforehand that your microphone or headset and camera are working properly. Do not access our services from a VPN since there are issues with the audio over such connections.

We have integrated Zoom video conferencing software into our Learning Space for our online training courses. If you are not authorised to use Zoom, please get in touch with us so we can make alternative arrangements for you to take part in our online training.

Your mandatory module

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
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Select your focus areas

Abonnement: PharmaFORUM Webcast International

jederzeit

Details
Learning Space
Global variations and lifecycle management

21.01. - 11.02.2026

Details
Learning Space
Global Regulatory Affairs Essentials

17. - 18.03.2026

Details
Learning Space
Marketing Authorisation Procedures in the EU

22.04.2026

Details
Learning Space
Pharmaceutical Marketing Authorisation and Market Access in the Middle East: GCC and National Markets

28. - 29.04.2026

Details
Learning Space
Marketing Authorisation Documents in the EU

05. - 06.05.2026

Details
Learning Space
Webcast: Update EU Pharma Legislation

08. - 25.06.2026

Details
Learning Space
Regulatory Lifecycle Management

10.06.2026

Details
Learning Space
EU Regulatory Strategy

09.07.2026

Details
Learning Space
Regulatory Affairs and GMP compliance in Eastern Europe

26. - 27.08.2026

Details
Learning Space
ExpertFORUM Global Regulatory Affairs

17. - 18.09.2026

Details
Learning Space
Marketing Authorisation in Latin America

23. - 24.09.2026

Details
Learning Space
Variations in Europe

28. - 29.09.2026

Details
Learning Space
e-Learning: EU Variation System and Procedures

jederzeit

Details
LMS
e-Learning: Common Technical Document and eCTD

jederzeit

Details
LMS