Webcode 60012501
01/01 - 31/12/2026
01/01 - 31/12/2026
A duration of a few weeks up to a maximum of 18 months, depending on the selected modules.
online
online
Event - 220€ plus tax
The base fee is 220 € plus VAT.
Additional fees apply for the elective online training modules you select during the booking process, as each module is priced individually.
The participation fee includes the mandatory e-learning course "Introduction to EU Marketing Authorisation". You then select at least two online training modules from our programme. Optional e-learning courses may be booked in addition.
Your total course fee depends on the number and scope of the modules you choose. Payment is due within 21 days of receiving the final invoice.
OPTIONS
Abonnement: PharmaFORUM Webcast International
+900,00 €
Global Regulatory Affairs Essentials
+1.350,00 €
Marketing Authorisation Procedures in the EU
+900,00 €
Pharmaceutical Marketing Authorisation and Market Access in the Middle East: GCC and National Markets
+1.800,00 €
Marketing Authorisation Documents in the EU
+1.350,00 €
Webcast: Update EU Pharma Legislation
+1.350,00 €
Regulatory Lifecycle Management
+900,00 €
EU Regulatory Strategy
+900,00 €
Regulatory Affairs and GMP compliance in Eastern Europe
+1.800,00 €
ExpertFORUM Global Regulatory Affairs
+1.350,00 €
Marketing Authorisation
in Latin America
+1.800,00 €
Variations in Europe
+1.800,00 €
e-Learning: EU Variation System and Procedures
+320,00 €
e-Learning: Common Technical Document and eCTD
+420,00 €
Event - 220€ plus tax
The base fee is 220 € plus VAT.
Additional fees apply for the elective online training modules you select during the booking process, as each module is priced individually.
The participation fee includes the mandatory e-learning course "Introduction to EU Marketing Authorisation". You then select at least two online training modules from our programme. Optional e-learning courses may be booked in addition.
Your total course fee depends on the number and scope of the modules you choose. Payment is due within 21 days of receiving the final invoice.
OPTIONS
Abonnement: PharmaFORUM Webcast International
+900,00 €
Global Regulatory Affairs Essentials
+1.350,00 €
Marketing Authorisation Procedures in the EU
+900,00 €
Pharmaceutical Marketing Authorisation and Market Access in the Middle East: GCC and National Markets
+1.800,00 €
Marketing Authorisation Documents in the EU
+1.350,00 €
Webcast: Update EU Pharma Legislation
+1.350,00 €
Regulatory Lifecycle Management
+900,00 €
EU Regulatory Strategy
+900,00 €
Regulatory Affairs and GMP compliance in Eastern Europe
+1.800,00 €
ExpertFORUM Global Regulatory Affairs
+1.350,00 €
Marketing Authorisation
in Latin America
+1.800,00 €
Variations in Europe
+1.800,00 €
e-Learning: EU Variation System and Procedures
+320,00 €
e-Learning: Common Technical Document and eCTD
+420,00 €
Verena Planitz
Conference Manager
+49 6221 500-655
v.planitz@forum-institut.de
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.
This qualification course provides a structured introduction to regulatory affairs while allowing you to set your own focus areas. It combines guided self-study with interactive online seminars to build a solid understanding of regulatory requirements for human medicinal products. Core principles of EU marketing authorisation form the foundation, with the option to deepen your knowledge through additional online trainings.
All trainings include comprehensive downloadable documentation and a certificate of participation. After completing all required modules, you will receive the FORUM certificate "Qualification Course Regulatory Affairs Manager".
The qualification course consists of one mandatory e-learning module and at least two elective online training modules.
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.
You begin with the mandatory e-learning "Introduction to EU Marketing Authorisation" and then choose at least two online training modules that match your interests. Upon successful completion of all required modules, participants receive the certificate "Qualification Course Regulatory Affairs Manager".
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, but you may also finish it within a few weeks, depending on your schedule.
When you book the qualification course, you register for the overall programme. You can select your elective modules individually during the booking process. Our team is happy to support you in choosing the right combination.
Verena Planitz - global regulatory affairs
v.planitz@forum-institut.de
+49 6221 500-655
Jean-Marie Bayhurst - EU regulatory affairs
j.bayhurst@forum-institut.de
+49 6221 500-685
The qualification course consists of:
- A base fee of €220 plus VAT
- Fees for the individual elective online training modules you select
- Optional additional e-learning modules, if desired
The mandatory e-learning "Introduction to EU Marketing Authorisation" is included in the base fee. The elective modules are priced separately, as their scope and duration vary. Your total course fee depends on the number of modules you choose. Optional e-learning courses may also be booked, but they are not included in the base fee and do not count toward the minimum requirement of two online training modules.
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.
This e-learning programme will familiarise you with the regulatory affairs principles involved in applying for a marketi...
28. - 29.04.2026
Details
