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 - 2,000€ plus tax
The qualification course shall consist of a minimum of 15.5 teaching units at a fee of EUR 2,000 (plus VAT) and may be extended by additional modules upon agreement. Each additional teaching unit shall be charged at EUR 140 (plus VAT). The total course fee shall be determined by the number and scope of the modules selected. Payment shall be due within 21 days of receipt of the final invoice.
OPTIONS
PharmaFORUM Webcast International (6 webcasts included)
+840,00 €
EU Regulatory Strategy
+910,00 €
Regulatory Affairs and GMP compliance in Eastern Europe
+1.540,00 €
Global variations and lifecycle management
+1.120,00 €
ExpertFORUM Global Regulatory Affairs
+1.330,00 €
Marketing Authorisation
in Latin America
+1.820,00 €
Variations in Europe
+1.820,00 €
Regulatory Affairs and CMC Conference
+980,00 €
Outsourcing & Vendor Oversight in Regulatory Affairs
+700,00 €
Update eCTD 4.0
+0,00 €
Marketing Authorisation Documents in the EU
+1.330,00 €
Regulatory Strategy for ASEAN
+0,00 €
ExpertFORUM Labelling
+0,00 €
Regulatory Operations - The Digital Imperative
+840,00 €
Update Biosimilars 2026
+560,00 €
EU Supply Shortage Management and the ESMP
+840,00 €
AI in Regulatory Writing
+0,00 €
e-Learning: EU Variation System and Procedures
+490,00 €
e-Learning: Common Technical Document and eCTD
+630,00 €
Event - 2,000€ plus tax
The qualification course shall consist of a minimum of 15.5 teaching units at a fee of EUR 2,000 (plus VAT) and may be extended by additional modules upon agreement. Each additional teaching unit shall be charged at EUR 140 (plus VAT). The total course fee shall be determined by the number and scope of the modules selected. Payment shall be due within 21 days of receipt of the final invoice.
OPTIONS
PharmaFORUM Webcast International (6 webcasts included)
+840,00 €
EU Regulatory Strategy
+910,00 €
Regulatory Affairs and GMP compliance in Eastern Europe
+1.540,00 €
Global variations and lifecycle management
+1.120,00 €
ExpertFORUM Global Regulatory Affairs
+1.330,00 €
Marketing Authorisation
in Latin America
+1.820,00 €
Variations in Europe
+1.820,00 €
Regulatory Affairs and CMC Conference
+980,00 €
Outsourcing & Vendor Oversight in Regulatory Affairs
+700,00 €
Update eCTD 4.0
+0,00 €
Marketing Authorisation Documents in the EU
+1.330,00 €
Regulatory Strategy for ASEAN
+0,00 €
ExpertFORUM Labelling
+0,00 €
Regulatory Operations - The Digital Imperative
+840,00 €
Update Biosimilars 2026
+560,00 €
EU Supply Shortage Management and the ESMP
+840,00 €
AI in Regulatory Writing
+0,00 €
e-Learning: EU Variation System and Procedures
+490,00 €
e-Learning: Common Technical Document and eCTD
+630,00 €
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 one mandatory e-learning module and at least two elective live online seminar modules.
1. Mandatory e-learning (self-study): "Introduction to EU Marketing Authorisation"
Aim: Build a solid foundation in regulatory affairs for medicinal products within the European Union.
2. Elective modules (live online seminars): individual focus areas
Aim: Deepen your expertise in the areas most relevant to your professional practice.
To receive your certificate, you are required to complete the mandatory e-learning module, which comprises 2.5 teaching units, and at least 13 additional teaching units from a minimum of two different elective live online seminar modules. This results in a minimum total of 15.5 teaching units.
The overall duration depends on the modules you choose and amounts to at least two working days. Exact timings are provided in the respective module descriptions. You have up to 18 months to complete the programme, but you may also finish it within just 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 can begin your online learning.
The minimum total course fee for the qualification course is EUR 2,000 (plus VAT).
The qualification course includes the following cost elements:
Mandatory e-learning module: The e-learning course "Introduction to EU Marketing Authorisation" comprises 2.5 teaching units and is charged at EUR 180 plus VAT.
Elective modules: To receive your certificate, you are required to complete at least 13 additional teaching units from a minimum of two different elective live online seminar modules. Elective modules are charged at EUR 140 per teaching unit plus VAT. If you wish, you may book further elective modules beyond the minimum certificate requirements at the same rate.
Payment is due within 21 days of receipt of the final invoice. Our General Terms and Conditions, as amended, shall apply. They are available at cancellation policy or can be provided 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 during the booking process. Our portfolio of EU and / or global regulatory affairs trainings is continuously expanding. New seminars are added regularly, giving you additional options for your qualification course.
Our team will be 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...
