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 two mandatory elective live online training modules you select during the booking process.
You may also book optional e.learning modules, but they do not count toward the requirement of two mandatory elective live online modules.
br>
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 €
Global variations and lifecycle management
+900,00 €
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 two mandatory elective live online training modules you select during the booking process.
You may also book optional e.learning modules, but they do not count toward the requirement of two mandatory elective live online modules.
br>
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 €
Global variations and lifecycle management
+900,00 €
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 EU and/or global regulatory affairs 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 three modules: one mandatory e-learning module and at least two elective live online seminars.
1. e-learning (self-study): "Introduction to EU marketing authorisation"
Aim: Develop a solid foundational understanding of regulatory affairs for medicinal products within the European Union.
2. Elective modules (live online seminars): individual focus areas
Aim: Specialise in your specific field of work within regulatory affairs.
The duration depends on your selected modules and amounts to at least three working days. Exact timings are provided in the module descriptions. You have up to 18 months to complete the programme, but you may also finish it within a few weeks.
After registering, you will receive your confirmation and access details for your customer portal, where you will find all relevant information and documents and start your online courses.
The qualification course consists of the following cost elements:
-Base fee: €220 plus VAT
-Fees for the two elective live online seminars that are mandatory
-Optional: fees for any additional live online seminar modules or optional e-learning modules you may wish to add
You choose at least two elective live online seminar modules. Optional e-learning modules may also be booked, but they do not count toward the mandatory requirement of two elective live online seminar modules.
All modules within the qualification course are offered at reduced package rates compared to individual booking. The exact module fees can be viewed on our website under the pricing section or the green booking button.
The fee is payable within 21 days of receiving the final invoice. Our General Terms and Conditions (as of 01 June 2024) apply. These can be viewed on cancellation policy or sent to you upon request.
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.
When booking the qualification course online, you select your elective modules directly in the booking process. Our portfolio of EU and/or global regulatory affairs trainings is continuously expanding. New seminars are added regularly, offering you additional options for your qualification course.
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
This e-learning programme will familiarise you with the regulatory affairs principles involved in applying for a marketi...
28. - 29.04.2026
Details
