Essential updates on new/revised (EMA) Guidelines/Papers
Webcode 26062452
Dr. Andreas Bonertz
Regulatory Affairs Expert, Langen
Dr Bonertz heads the Clinical Trials Unit of a federal institution, which is responsible for the authorisation of vaccines and biomedical medicinal products. He is also actively involved in various national and international committees of the EMA and EDQM, which play a key role in shaping the regulatory framework for the authorisation of medicinal products in the European Union.
Dr. Helmut Vigenschow
ViPharmaService, Burgrieden
Independent Consultant Dr Vigenschow worked for Merckle/ratiopharm for 30 years in leading positions, including in the areas of project management, regulatory affairs, pharmaceutical development, quality assurance and quality control. Dr Vigenschow has been working as an independent consultant for several years now.
19/06/2026
19/06/2026
from 09:00 am until 01:00 pm CET
You may dial in 30 minutes before the lecture starts
online
online
Event - 690€ plus tax
The participation fee includes documentation for download, a certificate, access to the Learning Space, and technical support, including a pre-meeting.
Event - 690€ plus tax
The participation fee includes documentation for download, a certificate, access to the Learning Space, and technical support, including a pre-meeting.
Dr. Birgit Wessels
Conference Manager
+49 6221 500-652
b.wessels@forum-institut.de
CMC changes: During the half-day training you will receive essential updates on new/revised (EMA) guidelines/papers focusing on Product Lifecycle Management (PLCM), Post Approval Change Management Protocol (PACMP) and stability testing.You'll benefit from the combination of regulatory authority perspectives and industry examples.
This seminar equips you, as CMC professional, with practical strategies to leverage the latest regulatory tools, including the newly published Q&As on PLCM documents and the revised Q&As on PACMP, to streamline your post-approval change management processes.
You'll gain clarity on these current regulatory updates, enabling you to make decisions tailored to your submission strategies.
The seminar goes beyond theory: Our speakers will share examples from PLCM and PACMP applications, providing you with practical insights into what works, what agencies look for during assessments, and how to navigate complex regulatory scenarios.
You'll benefit from both industry perspectives and "regulatory guidance", helping you avoid common pitfalls and align your strategies with agency expectations.
After having participated in the seminar, you will have
Welcome, introduction, expectations
Dr Helmut Vigenschow
Biobreak
Dr Andreas Bonertz
Dr Helmut Vigenschow
Recap and outstanding questions
End of training
This seminar is the basic module of our qualification programme "CMC-Specialist".
The course concept:
You are looking for this topic for several employees?
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We also offer this seminar as an in-house seminar.
Take advantage of the proven concepts of our open seminars and bring your employees to the same level of knowledge quickly and easily.
We will be happy to send you a non-binding offer.
Stay ahead of proposed regulatory changes in pharmaceutical stability testing. This "practical guide" helps you navigate the evolving landscape of EU and ICH requirements, with special focus on the upcoming ICH Q1 draft guideline set for adoption in late 2025.
https://www.forum-institut.com/stability-testing-of-drug-products
You need a reliable Internet connection to take part in our online events. To have the best possible learning experience, we recommend that you use the latest version of the Microsoft Edge or Google Chrome browsers. You will need a headset, loudspeaker or telephone to play the audio. Further information is available here. Please check beforehand that your microphone or headset and camera are working properly. Do not access our services from a VPN since there are issues with the audio over such connections.
We have integrated Zoom video conferencing software into our Learning Space for our online training courses. If you are not authorised to use Zoom, please get in touch with us so we can make alternative arrangements for you to take part in our online training.
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