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:
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.
| Name | Company/Institution |
|---|---|
| Kevin Lief (chair) | GSK |
| Beate Presser | Boehringer-Ingelheim |
| Christian Schmid | Roche |
| Jens Lamerz | Roche |
| Martin Otava | Johnson & Johnson |
If you are interested in joining the CMC SIG, please email Kevin Lief.
Our monthly webinar explores examples of innovative data visualisations relevant to our day to day work. Each month a new dataset is provided from a clinical trial or other relevant example, and participants are invited to submit a graphic that communicates interesting and relevant characteristics of the data.
The webinar will show how the estimand framework was applied in a Phase 3 trial in Alzheimer's disease.
This webinar will cover the history of cell/gene therapy, major regulatory advances, the role of quantitative scientists in drug development of these novel therapeutics, and discuss opportunities for innovation and product advancement.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
An introductory course giving an overview of the pharmaceutical industry and the drug development process as a whole, aimed at those with 1-3 years' experience. It comprises of six 2-day sessions covering a range of topics including Research and Development, Toxicology, Data Management and the Role of a CRO, Clinical Trials, Reimbursement, and Marketing.
This 2-day course is designed to provide a comprehensive understanding of the regulatory guidelines affecting statisticians in the pharmaceutical industry, including the latest updates in the field. The course will cover key International Council for Harmonisation (ICH) guidelines and other key regional regulatory agency documents.
This webinar will discuss opportunities in applying causal inference methodology during the analysis of RCT data.
Lea Vaas will present how replacement of concurrent control animals by Virtual Control Groups (VCGs) in systemic toxicity studies may help in contributing to the 3R's principle of animal experimentation: Reduce, Refine, Replace.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
This apprenticeship role offers a unique opportunity to learn and work in a global healthcare consultancy company alongside a team of statisticians, psychometricians and programmers.
We have exciting new opportunities available for Study Statisticians, Support Statisticians and Exploratory Statisticians at various levels.
