- Online training -
Webcode 25122452
Dr. Hans Rensland
RACON Regulatory Affairs Consulting GmbH, Berlin
Dr Hans Rensland has 30 years of experience in clinical research and regulatory affairs. With his many years of professional experience in the pharmaceutical industry, he founded his own consulting company in 2012.
More information please click here.
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.
09/12/2025
09/12/2025
9:00 am until 5:00 pm - online seminar
You may dial in 30 minutes before the training starts
online
online
Veranstaltung - 1,290 € zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Veranstaltung - 1,290 € zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Dr. Birgit Wessels
Conference Manager
+49 6221 500-652
b.wessels@forum-institut.de
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 "advanced" CMC writing with you, providing you with real-world examples and practical tools.
Our comprehensive training program equips you with practical tools and expertise to confidently prepare CMC documents for CTD submission, with a strong focus on language, structure, and concept.
Following an introduction to general conventions in CMC writing our experts will guide you through considerations for creating the development plan, including specific aspects for different dosage forms: solid, liquid and sterile products.
You will learn how to compile the description of the manufacturing process correctly and receive best practices for working with service providers. You'll also gain valuable insights into the creation of CTD submissions, benefiting from real-world examples and extensive regulatory experience.
Upon completion of this seminar, you will be able to present your data clearly and in full compliance with regulatory standards, ensuring consistency and logical flow that facilitates regulatory review and approval.
After having participated in the compact course, you as "advanced" CMC writer will have learned how to
Welcome, introduction, expectations
Dr Helmut Vigenschow
Bio break
Dr Hans Rensland and Dr Helmut Vigenschow
Lunch break
Dr Helmut Vigenschow and Dr Hans Rensland
Bio break
Dr Helmut Vigenschow
Dr Hans Rensland
Dr Hans Rensland
Summary and outstanding questions
End of seminar
This seminar can be taken as elective module as part of our qualification program to become a CMC-Specialist.
The course concept:
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FORUM Institut’s all-in-one training platform uses the latest teaching methods.
All our online training courses take place in the Learning Space, our holistic learning environment with many features that promote effective and sustainable learning.
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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This seminar can be taken as elective module as part of our qualification program to become a CMC-Specialist.
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