AIMS SIG - Open-Source Lunch Bites
Our monthly webinar series allows attendees to gain practical knowledge and skills in open-source coding and tools, with a focus on applications in the pharmaceutical industry.
CMC Statistical Network Europe
Purpose
Chemistry, Manufacturing and Control Statisticians, working in Europe for pharmaceutical companies and CROs active in R&D, and we seek to collaborate and exchange in any precompetitive topic of our field.
Formed as a SIG in 2024, we seek to:
- Arrange webinars to share various technical, novel and existing approaches.
- Provide a forum for CMC Statisticians in Europe to comment on guidelines from regulatory agencies.
Objectives
CMC Statistical Network Europe (CSNE) are the application of statistics, data science, modelling and computing methods related to CMC technical development. The CSNE chair and steering committee are responsible for the oversight and implementation of CSNE initiatives as well as those of the CSNE Working Group (CSNEWG).
A. Primary interests of the CSNE:
(i) The biological, chemical, physical, engineering, analytical and pharmaceutical sciences for formulation, product development and manufacturing.
(ii) Regulatory issues governing statistical practices associated with (i).
b. In pursuit of these primary interests the CSNE seeks to:
(i) Promote the improvement of policies and regulations governing statistical practices and associated guidelines specific to CMC space.
(ii) Improve the practice of statistics as related to design, computing, evaluation, and reporting in the CMC space.
(iii) Promote research that adds tools to improve decision making and further the understanding of scientific studies in the CMC space.
Who we are
| Name | Company/Institution |
|---|---|
| Kevin Lief (chair) | GSK |
| Beate Presser | Boehringer-Ingelheim |
| Christian Schmid | Roche |
| Jens Lamerz | |
| Martin Otava | Johnson & Johnson |
How to get in touch
If you are interested in joining the CMC SIG to hear about our events, please email Kevin Lief.
SIG News
Round Table Discussion Group: ICH Stability ICH Q1/Q5C Revision - 24th July 12 noon CET
We held our inaugural discussion group, for members only, to share thoughts and comments on the current revision. This was a very successful event, with a lively discussion, sharing ideas and thoughts from a wide range of CMC statisticians.
If you are not currently a member of our SIG, and would like to participate in our future events, please e-mail Kevin.R.Lief@gsk.com to join 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.
non-SIG Events
Here are a couple of upcoming events that may be of interest:
CMC Statistical Network Europe will be represented at the EFSPI Regulatory Statistics workshop from 10th to 12th September, at Biozentrum, Basel.
The European Network for Business and Industrial Statistics (ENBIS) annual conference will be hosted by the University of Piraeus and will take place at the central building in the city center of Piraeus (Greece), from September 14th to 18th.
The IABS 11th Annual Statistics Workshop organized by the INTERNATIONAL ALLIANCE FOR BIOLOGICAL STANDARDIZATION will take place as a Virtual Meeting. This years topic is: BIG TENT STATISTICS - CONVEYING THE IMPORTANCE OF STATISTICAL CONTRIBUTIONS
October 20-23, 2025 | Virtual Meeting
