CMC compliance: What to do now and what ICH Q3E will bring
Webcode 26092454
Dr. Katrin Buss
Expert pharmaceutical quality and regulatory affairs, Bonn, GERMANY
Samo Kuzmic
Sandoz Lek d.d., Ljubljana, SLOVENIA
Project Manager | Global Development Center of Excellence for Extractables & Leachables Lead
17/09/2026
17/09/2026
from 9:00 am until 1:00 pm CET - Online training
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 PreMeeting.
Event - 690€ plus tax
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
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 of ICH Q3E.
This seminar provides you with a comprehensive overview of the draft regulatory framework of the ICH Q3E, specific CMC requirements, and practical implementation strategies based on both authority and industry perspectives.
The seminar covers the regulatory framework and CMC-specific requirements outlined in the draft guideline, including study design, safety assessments, and Module 3 documentation.
Beyond that, the seminar will also explore how ICH Q3E integrates with the existing E&L guidance documents, such as the USP E&L chapters and BPOG, providing a clear understanding of how these standards work together to support a robust global regulatory strategy.
After having participated in the seminar you will be equipped to navigate the upcoming requirements confidently and proactively prepare your organisation for the implementation of ICH Q3E.
After having participated in the course, you are equipped to
Welcome, introduction, expectations
Dr Katrin Buss
Biobreak
Samo Kuzmic
Dr Katrin Buss
Biobreak
Samo Kuzmic
End of seminar
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This seminar can be taken as elective module as part of our qualification course program to become a CMC Specialist.
The course concept:
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