Regulatory Affairs
Enhance your expertise in Regulatory Affairs. Our training courses on medicinal product approval, including CTD, CMC, eSubmission, and MRP and DCP procedures, as well as maintenance topics such as variations, prepare you for marketing authorisation and lifecycle management responsibilities.
Thema
Dates
Format
Qualification Course: Qualified Person for Pharmacovigilance (QPPV)
- Modular training programme consisting of three selected seminars for Qualified Persons for Pharmacovigilance -Gain insight into the legal framework and core responsibilities of the Qualified…
01.06.2026 - 31.12.2027
Modulare Weiterbildung
Details
Qualification Course: Head of Pharmacovigilance
- Modular training programme consisting of three selected seminars and one elective module for Heads of Pharmacovigilance -Learn the responsibilities and legal aspects of managing a PV system and…
01.06.2026 - 31.12.2027
Modulare Weiterbildung
Details
Regulatory Affairs Starter Pack
Three e-Learning programmes in one bundle: Get a solid foundation in EU marketing authorisation procedures, the EU variation system and the Common Technical Document (eCTD). Your fast track into EU…
25.07.2026 - 31.12.2026
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Details
Qualification Course Regulatory Affairs Manager
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…
01.01.2026 - 31.12.2026
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Details
Modern Risk Minimisation for Safety Professionals
In this online seminar, you will learn how to design, implement and evaluate effectively (additional) risk minimisation measures (RMMs). You will gain a clear understanding of current regulatory…Language: English
04/12/2026
Online-Seminar
Details
Repurposed drugs - Access to the European Market
This online seminar equips regulatory affairs, IP, legal and market access professionals with practical strategies to navigate the complex journey from drug repurposing to European market…Language: English
12/11/2026
Online-Seminar
Details
Regulatory Strategy for ASEAN
This webcast series provides a practical overview of regulatory approval pathways, dossier requirements and market entry considerations for pharmaceutical products across key ASEAN markets. You will…Language: English
19 - 25/11/2026
Serie (abgeschlossen)
Details
Global variations and lifecycle management
Global variations and lifecycle management - covering key regions: USA, Asia (China, Japan, South Korea), LATAM (Central America, Brazil), and Gulf Cooperation Council (GCC). Take this opportunity to…Language: English
31/08 - 21/09/2026
Serie (abgeschlossen)
Details
Qualification course: CMC-Specialist in Regulatory Affairs
With this qualification course, you can continue your education in a structured manner in all CMC topics, with a technical focus on development methods, manufacturing processes, CMC documents, change…Language: English
01/09/2025 - 31/12/2026
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Details
Abonnement: PharmaFORUM Webcast International
Stay informed with updates from our global and local experts, who will provide the latest regulatory and legislative insights every two months. In 2026, topics will include CMC documentation,…Language: English
01/11/2026 - 31/10/2027
Abonnement
Details
Pharmacovigilance Key Performance Indicators
Are you involved in the implementation and ongoing adaptation of the PV system? In this online course you will learn how to use the right Key Performance Indicators (KPIs) for your PV system to…Language: English
28/09/2026
Online-Seminar
Details
Update eCTD 4.0
Get up to speed on eCTD 4.0: EU timelines, technical changes, transition requirements and pilot learnings - all in one focused half-day session including a live demo.Language: English
27/10/2026
Online-Seminar
Details
Radiopharmaceuticals: A practical CMC and quality perspective
Radiopharmaceuticals are facing a pivotal regulatory moment. This seminar brings together experts from a regulatory authority, a CDMO, and a sponsoring company to provide practical, up-to-date…Language: English
12/11/2026
Online-Seminar
Details
CMC dossier requirements: FDA vs EU
CMC dossier requirements FDA vs EU: After having attended the seminar you will feel secure writing and maintaining the quality dossier for US marketing authorisations of small and large molecules…Language: English
06/10/2026
Online-Seminar
Details
ExpertFORUM Global Regulatory Affairs
This online conference offers compact expert talks and diverse perspectives on global regulatory strategies, digital transformation and evidence generation. Expect focused insights, practical…Language: English
17 - 18/09/2026
Online-Seminar
Details
Contact
We are happy to provide you with personal and individual advice.
Our professional development portfolio is extensive. We would be pleased to discuss your requirements with you personally and help identify the most suitable options from our range of offerings. Let our professional development experts advise you and feel free to contact us today.
Jean-Marie Bayhurst
Conference Manager Pharma & Healthcare
+49 6221 500-685
j.bayhurst@forum-institut.de