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.
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Qualification course: CMC-Specialist in Regulatory Affairs
This qualification course offers you the opportunity to undertake structured further training in CMC topics. You will receive up to 35 lesson units for a fixed price of €4,500 + VAT; additional…
01.09.2025 - 31.12.2026
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Recording: Update EU Pharma Legislation - The Full Series
This bundle brings together all four recorded modules of the live webcast series "Update EU Pharma Legislation", held in June 2026. Each module is approximately 90 minutes long and is also available…
01.01.2026 - 31.12.2027
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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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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
EU Supply Shortage Management and the ESMP
Stay up to date on EU supply shortage management: reporting obligations, the Critical Medicines Act and practical ESMP guidance - in two focused half-day sessions.Language: English
03 - 04/12/2026
Serie (abgeschlossen)
Details
Preclinical development: From bench to first in human
Preclinical drug development: The online training course for preclinical newcomers with a focus on small molecules and biologics. Learn about the fundamentals and regulatory requirements and take the…Language: English
01 - 03/12/2026
Online-Seminar
Details
AI in Pharma R&D
AI in Pharma R&D: During the half-day seminar you will learn how to navigate compliance requirements due to regulatory frameworks, you will explore how structured content enables AI-supported document…Language: English
17/11/2026
Online-Seminar
Details
CMC writing excellence: From development data to CTD content
Would you like to feel more confident presenting your CMC/quality data clearly and in full compliance with regulatory standards? Our two experts will share their extensive regulatory expertise in…Language: English
10/12/2026
Online-Seminar
Details
e-Learning: Common Technical Document and eCTD
Do you need know how regarding CTD/eCTD & CMC? Then this e-learning programme is the fast track to becoming knowledgeable in this field. No prior dossier experience is required.Language: English
available immediately
e-Learning
Details
e-Learning: EU Variation System and Procedures
This e-Learning programme will provide you with detailed knowledge on the classification, grouping and submission of variations in the EU.Language: English
available immediately
e-Learning
Details
e-Learning: Introduction to EU Marketing Authorisation
This e-learning programme will familiarise you with the regulatory affairs principles involved in applying for a marketing authorisation in Europe (MRP, DCP, CP) . It will also introduce you to…Language: English
available immediately
e-Learning
Details
AI in Regulatory Writing
This seminar explores how artificial intelligence can be effectively and responsibly integrated into regulatory writing processes. You'll gain insights into legal requirements, learn about AI tools…Language: English
09/12/2026
Online-Seminar
Details
e-Learning: Global Stability
Global Stability: This e-Learning provides a comprehensive introduction to global stability testing for pharmaceutical products (chemical and biological products). Including an update on revision of…Language: English
available immediately
e-Learning
Details
e-Learning: CTD Module 3
This e-Learning programme will familiarise you with the data requirements in CTD Module 3.Language: English
available immediately
e-Learning
Details
Biopharmaceuticals
The compact course with a content focus on the development, production and analytics of biotech drugs. Secure your place and qualify now! All three course days can be booked individually (single day =…Language: English
02 - 04/12/2026
Online-Seminar
Details
Global CMC requirements: focus on Latin America/Latam countries
CMC requirements in Latin America with focus Mexico, Brazil, Colombia, Argentina, Chile, and Peru. The seminar (2 half days) is comfortable to integrate into your daily work routine.Language: English
03 - 04/12/2026
Online-Seminar
Details
Update Biosimilars 2026
This seminar covers the key regulatory shifts shaping the biosimilars landscape in 2026. Explore how the revised EU pharmaceutical legislation, the EU Biotech Act, and global regulatory convergence…Language: English
26/11/2026
Online-Seminar
Details
ExpertFORUM Labelling
This online conference covers key EU regulatory developments shaping labelling in 2026, practical best practices for compliant day-to-day labelling, progress on ePI and QRD updates, and the latest AI…Language: English
19 - 20/11/2026
Online-Seminar
Details
Marketing Authorisation Documents in the EU
This seminar provides an in-depth exploration of the marketing authorisation dossier and the electronic submission process, focusing on the CTD structure and Modules 1-5. Participants will gain…Language: English
03 - 04/11/2026
Online-Seminar
Details
EU GMP Revision: Chapter 4, Annex 11, Annex 22
EU GMP Revision: Are you prepared for the guideline changes in Chapter 4 (Documentation), Annex 11 (Computerised Systems), and Annex 22 (AI)? Receive your update - presented in a simple and…Language: English
11/11/2026
Online-Seminar
Details
Update: Method validation & analytical methods transfer
Master GMP-compliant method validation and analytical method transfer in one focused online seminar. Walk away with practical knowledge of current ICH and FDA requirements, solid statistical…Language: English
18/11/2026
Online-Seminar
Details
Global stability: From regulatory framework to practical application
Navigate global stability requirements with confidence - from ICH, FDA and EMA frameworks to real-world application. In this interactive half-day seminar, you work through practical case studies,…Language: English
26/11/2026
Online-Seminar
Details
Combination products: From CMC and quality data to a submission-ready regulatory dossier
The EU regulatory landscape for drug-device combination products is highly demanding. This seminar walks you through the regulatory landscape, from MDR, EU GMP, and ICH guidelines to marketing…Language: English
24/11/2026
Online-Seminar
Details
Current Guideline Revisions in CMC
CMC in transition: Successfully implementing guideline updates - what CMC managers need to know now! Benefit from the expertise of our two experts and plan strategically.Language: English
25/11/2026
Online-Seminar
Details
Mastering ICH Quality Guidelines: From Development to Lifecycle Management
To make the most of ICH Q12 opportunities, you have to be aware of the relation between ICH guidelines Q8 to Q12 and how to properly integrate them. Our experts will go through each guideline and…Language: English
18/11/2026
Online-Seminar
Details
CMC Management in Regulatory Affairs
This online training will give you in-depth knowledge on the CMC requirements for marketing authorisation. Including an update on the new (Draft) ICH M4Q(R2) and the Draft of the Revision of the…Language: English
09 - 10/11/2026
Online-Seminar
Details
Outsourcing & Vendor Oversight in Regulatory Affairs
Overview of RA outsourcing & vendor oversight: risk-based vendor selection, governance and compliance controls. Practical and compact in just half a dayLanguage: English
01/10/2026
Online-Seminar
Details
Variations in Europe
Variation regulation, new classification guideline, eSubmission and variation management: All processes explained in this online course.Language: English
28 - 29/09/2026
Online-Seminar
Details
Marketing Authorisation in Latin America
An interactive online seminar to explore real regulatory cases and challenges in marketing authorisation and lifecycle management across Mexico, Argentina, Colombia, Peru, Chile and Brazil - led by…Language: English
23 - 24/09/2026
Online-Seminar
Details
Toxicology and beyond: Safety assessment in drug development
During our online training "Toxicology and beyond: Safety assessment in drug development" you will build a solid toxicological know-how basis and will be informed about the inclusion of toxicological…Language: English
28 - 29/09/2026
Online-Seminar
Details
Extractables & Leachables: Current CMC requirements in light of the upcoming ICH Q3E
E&L and CMC compliance: After having participated in the seminar you will be equipped to navigate the upcoming requirements confidently and proactively prepare your organisation for the implementation…Language: English
17/09/2026
Seminar
Details
Regulatory Affairs and CMC Conference
The event will cover recent updates and practical implications of the EU pharmaceutical legislation, the application of AI in RA, and the new EU Variation regulation. Additionally, it will address the…Language: English
29/09/2026
Online-Seminar
Details
APIs in the dossier: Quality data, e-submission, global regulatory strategy
Are you a professional responsible for preparing quality documentation for active pharmaceutical ingredients (APIs) and their starting materials in the field of market authorisation? Then this is the…Language: English
29 - 30/09/2026
Online-Seminar
Details
CMC Writing
You as "beginner" or "refresher" would like to feel more secure writing CMC documents? Our experts will provide you with practical tips and tricks and share their experiences with you. After attending…Language: English
24/09/2026
Online-Seminar
Details
Global CMC requirements: focus on Asia, Japan, and Eastern Europe
CMC requirements in China, Japan, South Korea, India and Russia/EAEU. Meet our three experts to get an update on the current requirements in the different regions and discuss your individual issues…Language: English
10/09/2026
Online-Seminar
Details
Market Access of Biosimilars in Europe
Biosimilar uptake in Europe, Aut idem in Germany - these are the challenges for regulatory affairs and market accessLanguage: English
28/09/2026
Online-Seminar
Details
Regulatory Affairs and GMP compliance in Eastern Europe
This online training offers comprehensive insights into Regulatory Affairs, CMC, and GMP requirements, with a focus on the latest updates and developments in EAEU countries.Language: English
26 - 27/08/2026
Online-Seminar
Details
Recording: Update EU Pharma Legislation - Environmental risk assessment (ERA)
This recording delivers a clear overview of the evolving ERA requirements under the EU pharmaceutical reform. In approximately 90 minutes, you will understand the current legal framework, the changes…Language: English
e-Learning
Details
Recording: Update EU Pharma Legislation - Supply shortages and supply security
This recording delivers a clear overview of the new supply shortage obligations under the EU pharma reform. In approximately 90 minutes, you will understand the new prevention and risk planning…Language: English
e-Learning
Details
Recording: Update EU Pharma Legislation - The legal framework part 2
This recording delivers a clear overview of the changes to regulatory protection periods under the EU pharmaceutical reform. In approximately 90 minutes, you will understand the new Bolar exemption…Language: English
e-Learning
Details
Recording: Update EU Pharma Legislation - The legal framework part 1
This recording delivers a clear overview of the current EU pharmaceutical legislative framework. In approximately 90 minutes, you will understand the status of the legislative process, the scope of…Language: English
e-Learning
Details
Regulatory Operations - The Digital Imperative
This seminar covers the key drivers of digital transformation in Regulatory Operations - from data quality and AI-driven automation to IDMP, eCTD 4.0, and ePI. Across two half-day sessions, you will…Language: English
24 - 25/11/2026
Serie (abgeschlossen)
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
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
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