SIG News
New - Round Table Discussion Group: ICH Stability ICH Q1/Q5C Revision - 22nd July 12 noon CET
Join our inaugural discussion group, for members only, to share thoughts and comments on the current revision. Welcome to come along and discussl or listen to others viewpoints. Take away how other CMC statisticians view the draft revision, and share as you see appropriate.
If you are not currently a member of our SIG, please e-mail Kevin.R.Lief@gsk.com to join and participate in the discussion!
New CMCSNE Workshop Announcement – Stability Modelling, Tuesday 21st October:
Firstly, we have the exciting news that we will hold an online workshop on the topic of stability modelling on the 21st October 2025. This will be a fantastic opportunity to delve into this crucial area and share insights with a broader audience.
If you are interested in presenting a contribution (of about 20-30 minutes), please e-mail Martin Otava (motava@ITS.JNJ.com) with a short proposal (one or two sentences).
Opportunity to Comment on ICH Q1 Revision:


The Steering Team wish to raise awareness that ICH are gathering comments on the stability testing of drug substances and drug products, via the Q1 Expert Working Group. The ICH Quality Guidelines website states:
“Further to the ICH Management Committee’s endorsement of the Q1/Q5C Concept Paper and Business Plan in November 2022, the Q1/Q5C EWG was established to revise the current ICH Stability Guideline Series Q1A-F and Q5C by:
- Streamlining the series, combining the various guidelines into a single guideline focused on core stability principles;
- Promoting harmonised interpretation by addressing potential gaps and areas of ambiguity; Addressing additional technical issues, including relevant stability strategies and innovative tools that strengthen the application of risk management;
- Considering inclusion of new topics, such as stability considerations for advanced therapies.
The envisioned result is a combined guideline, ICH Q1, with integrated annexes and/or appendices that address specific topics beyond the core stability recommendations and principles. Addressing drug product types including substances, intermediates, and devices.”
Questions from CSNE Steering Team:
- For future topics of interest to CMC statisticians, would you be interested in providing feedback via our Special Interest Group, to then feed into agencies such as ICH?
Please contact Kevin (Kevin.R.Lief@gsk.com)
Opportunity to Run and Host Part of the PSI introduction to Industry training Course:

There is an opportunity for companies to host the PSI Introduction to Industry Training (ITIT) course. This is a 1.5 to 2-day session that is run by the host company, with content provided by the host. If your company is interested in hearing the background information on what is involved in hosting this course, please contact " Kevin.R.Lief@gsk.com" for further information.