White paper

CMC Management in Regulatory Affairs

CMC Management in Regulatory Affairs

From the CMC Manager's everyday business life
This whitepaper is AI developed using NotebookLM and edited by Dr Birgit Wessels.


As a CMC Manager, every day brings new challenges — from nitrosamine risk assessments to post-approval variations, supplier audits to regulatory submissions. Balancing compliance demands with innovation pressures while ensuring product quality requires strategic focus and clear priorities. This whitepaper presents the essential priorities drawn from real-world experience to help CMC professionals excel in today's demanding regulatory environment.

Download now the white paper 'CMC Management in Regulatory Affairs – From the CMC Manager's everyday business life'.

We wish you many new insights while reading.




 

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CMC Management in Regulatory Affairs

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Events for „regulatory affairs“

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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 management, and much more.

online 01/01/-31/12/2026
Qualification Course: Head of Pharmacovigilance

Combined offer of three compulsory seminars plus one elective module for (future) Heads of the Pharmacovigilance Department - learn the responsibilities and legal aspects of managing a PV system and its staff, and select an elective module according to your individual interests.

online 01/01/-31/12/2025
Qualification Course: Qualified Person for Pharmacovigilance (QPPV)

Combination of three selected seminars - with this qualification course, you will first gain insight into the legal aspects and general responsibilities of the Qualified Person for Pharmacovigilance (QPPV). You will then deepen your professional and practical knowledge to perform your role more effectively.

online 01/01/-31/12/2025
Global CMC requirements: focus on Asia, Japan, and Eastern Europe

LAST CALL! - REGISTRATION DEADLINE: 2.09.2025 - Four live webcasts à 2 hours every week: CMC requirements in China, India, Japan, South Korea and Russia/EAEU. Meet our four experts to get an update on the current requirements in the different regions and discuss your individual issues with them. You are interested in one webcast only or a group account? Contact us!

online 16/09 - 07/10/2025
Masterclass: Local QPPV, EU QPPV, and Head of PV

Are you experienced in pharmacovigilance and looking for in-depth knowledge on managing a PV system and leading your team? Do you have specific questions about your role as responsible person? Then this online event is for you! Gain insights and expertise - from experts for experts.

online 26/09/2025
Abonnement: PharmaFORUM Webcast International

Our global and local experts will update you every two months with the latest regulatory and legislative developments. Thus, you will always have the essential information and trends in regulatory affairs at your fingertips!

online
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 in a profitable way. Reserve your seat now and be part of this insightful session!

online 06/10/2025
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 (chemicals and biologic).

online 07/10/2025
An Introduction for Pharmacovigilance Managers

Are you new to pharmacovigilance and looking to kick-start your career? Then this online course is just for you. Gain a comprehensive overview of pharmacovigilance, regulatory requirements in the EU and implementation in only two days. Take the next step in your professional growth - enrol now!

online 20 - 21/10/2025
online 24-25/03/2026
Pharmacovigilance Auditing

Do you want to independently plan and conduct pharmacovigilance audits? Then take this opportunity to become an "Auditor for Good Pharmacovigilance Practices". Secure your place on our compact, interactive online course. Book now!

online 27 - 28/10/2025
ExpertFORUM Labelling

This online conference covers EU regulatory developments, best practices for patient-centric labelling, digital transformation through ePI, and the latest innovations in labelling technology.

online 27 - 28/10/2025