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: AI Management in the Pharmaceutical Industry
A combination of a two-day mandatory foundation course, "AI in Pharma: Foundations, Use Cases and Implementation in Europe," and an additional elective day in a functional area of your choice, such as…
01.01.2027 - 31.12.2027
Modular Continuing Education
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…
01.01.2027 - 31.12.2027
Modular Continuing Education
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…
01.01.2027 - 31.12.2027
Modular Continuing Education
Details
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
Modulare Weiterbildung
Details
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
Modulare Weiterbildung
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
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
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
09/11/2026
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
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
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
Series (completed)
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
Series (completed)
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
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
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
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
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
Series (completed)
Details
Modern Risk Minimisation for Safety Professionals
This one-day advanced online course covers the regulatory requirements and practical implementation of (additional) risk-minimisation measures, from their selection through to their evaluation.Language: English
04/12/2026
Online-Seminar
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
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: 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
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: 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
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
eLearning
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: Medical Devices Basics - A Quick Introduction
Gain essential knowledge for your entry into the medical device industry in just 90 minutes! Understand regulations, market access, and vigilance with our compact e-learning.Language: English
available immediately
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
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 - 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 - 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
Market Access Starts in Regulatory Affairs
Designed for Regulatory Affairs, Market Access and Outcomes Research professionals, this seminar shows why Market Access starts in Regulatory Affairs and how the key interfaces shape the path to a…Language: English
25/01/2027
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
16/02/2027
Online-Seminar
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
25/02 - 18/03/2027
Series (completed)
Details
Webcast: Navigating AI in Regulatory Affairs
This webcast series examines the use of artificial intelligence in regulatory affairs from legal, operational and strategic perspectives.Language: English
02 - 16/03/2027
Series (completed)
Details
All about ATMP
The online training with details on development, quality, CMC, approval and market access (including an update on the upcoming EU HTA: first experiences with ATMPs) for advanced therapy medicinal…Language: English
08 - 09/03/2027
Online-Seminar
Details
Webcast: Update EU Pharma Legislation
This online webcast series provides a concise update on the EU Pharmaceutical Package. Across five two-hour modules, you learn about key regulatory changes, revised authorisation and protection rules,…Language: English
06 - 27/04/2027
Series (completed)
Details
NIS, PASS and RWE in the Post-Authorisation Phase
This one-day online seminar provides a practical, EU-focused overview of NIS, PASS, RWD and RWE and how you select and manage an appropriate study to investigate a safety concern after marketing…Language: English
06/04/2027
Online-Seminar
Details
Marketing Authorisation Procedures in the EU
This seminar provides an in-depth exploration of EU drug marketing authorisation, focusing on regulatory frameworks, application types and procedures. It covers mutual recognition, decentralised and…Language: English
22/04/2027
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
28/04/2027
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
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
04 - 05/05/2027
Online-Seminar
Details
CMC for Biologicals
Get your know-how on creating and maintaining quality data for biotech products in our online training. Including an outlook on the new (Draft) ICH Q1 and ICH M4Q(R2).Language: English
06/05/2027
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