Quality Assurance, Manufacturing & Logistics
GMP and GDP expertise combined with practical insights for your work in quality assurance, quality control, manufacturing and logistics. From the Qualified Person to the Responsible Person for wholesale distribution – comprehensive knowledge to ensure your GMP/GDP compliance.
Thema
Dates
Format
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
e-Learning: GDP - Basic Training
This e-Learning programme will provide you with knowledge on Good Distribution Practice in today's pharmaceutical industryLanguage: English
available immediately
e-Learning
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
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
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 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: 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
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
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
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
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
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
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
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.
Dr. C. Michaela Gottwald
Conference Manager Healthcare
+49 6221 500-610
m.gottwald@forum-institut.de