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.
In addition, fees apply for two mandatory online training modules, which must be booked separately.
The total course fee depends on the overall learning scope and the individual module selection. Payment is due within 21 days of receipt of the final invoice.
>>>The participation fee includes the e-learning course "Introduction to EU Marketing Authorisation" as well as at least two freely selectable online training modules. Optional e-learning courses are excluded. All trainings include comprehensive documentation available for download and a certificate of participation. Upon successful completion of all modules, participants are awarded the FORUM certificate "Qualification Course Regulatory Affairs Manager".<<<
OPTIONS
Abonnement: PharmaFORUM Webcast International
+900,00 €
Global variations and lifecycle management
+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.
In addition, fees apply for two mandatory online training modules, which must be booked separately.
The total course fee depends on the overall learning scope and the individual module selection. Payment is due within 21 days of receipt of the final invoice.
>>>The participation fee includes the e-learning course "Introduction to EU Marketing Authorisation" as well as at least two freely selectable online training modules. Optional e-learning courses are excluded. All trainings include comprehensive documentation available for download and a certificate of participation. Upon successful completion of all modules, participants are awarded the FORUM certificate "Qualification Course Regulatory Affairs Manager".<<<
OPTIONS
Abonnement: PharmaFORUM Webcast International
+900,00 €
Global variations and lifecycle management
+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 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.
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".
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.
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
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