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:

  1. Arrange webinars to share various technical, novel and existing approaches.
  2. 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 Roche
Martin Otava Johnson & Johnson

How to get in touch

If you are interested in joining the CMC SIG, please email Kevin Lief.

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