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 | |
| Martin Otava | Johnson & Johnson |
If you are interested in joining the CMC SIG to hear about our events, please email Kevin Lief.
SIG News
Inaugural Workshop Held - Dissolution Testing: Time for Statistical (r)Evolution, 18th March 2025
The CMC Statistical Network Europe steering team held our inaugural webinar, which focussed on the topic "Dissolution Testing: Time for Statistical (r)Evolution.".
Many thanks to our speakers, Thomas Hoffelder from Boehringer Ingelheim and Stephen Karanja from J&J.
The slide packs from the workshop can be found here:
Hoffelder Disso Profile Stats and Karanja Disso Profile Robustness Design and Analysis
And to all the participants with questions that led to a great discussion. The steering committee appreciated your active participation!
SIG Present to the EMA Quality Innovation Group, November 2024
Beaté Presser and Kevin Lief on 20th November 2024, presented at Day 2 of the European Medicines Ageny Quality Innovation Group, Listen and Learn Focus Group meeting on Platform Technologies. The meeting agenda is HERE, the meeting summary will posted once available.
SIG Launched at the CS Conference, September 2024
Fantastic to meet everyone at the conference, our launch slides are attached: CMC Statistics Network Europe NCS Conf 2024 Sept
non-SIG Events
One or more of the steering committee hope to attend the ENBIS Spring meeting, May 29-30 2025, titled "Quality by Design (QbD) & Process Analytical Technology (PAT): Statistical, AI and 'Grey' Approaches"
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.
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 book club’s usual focus is to read and discuss professional development books. In this short format event you can more easily develop you career without the commitment of reading the whole book - simply listen to the 1-hour long podcast before joining the interactive session on 21 May.
This webinar is organised by the RWD SIG and the Historical Data SIG. We will review recent methods, applications, and tools of integrating subject-level-data from clinical trial with external data using Bayesian methods and/or causal inference methods.
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 will be a 45 minute webinar which will explain the topic presented in the published paper, ‘Applying the Estimand Framework to Clinical Pharmacology Trials with a Case Study in Bioequivalance’. There will be 15 minutes for a panel Q&A with some of the authors following the presentation.
This 1-hour webinar will be an opportunity to hear about the methodology and first results of the iRISE consortium. iRISE is working towards a better understanding of reproducibility and the interventions that work to improve it. At the end of the presentation there will also be the opportunity to ask questions.
This one-day event focuses on the comprehensive management of transitioning to R/Open-Source, addressing the challenges and providing actionable insights. Attendees will participate in sessions covering essential topics such as training best practices, creating strategic plans, making the case to senior management, and managing both statistical and programming aspects of the transition.
This course is aimed at biostatisticians with no or some pediatric drug development experience who are interested to further their understanding. We will give you an introduction to the pediatric drug development landscape. This will include identifying the key regulations and processes governing pediatric development, a discussion on the needs and challenges when conducting pediatric research and a focus on the ways to overcome these challenges from a statistical perspective.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
The program will feature insightful sessions led by distinguished invited speakers, alongside a poster session showcasing the latest advancements in the field. Further details will be provided.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
The Institute of Cancer Research are seeking to appoint a Research Group Leader to join The CRUK Clinical Trials and Statistics Unit at the ICR.
This is an exciting, new opportunity for an experienced Statistician looking to take the next step in their career. Offered as a remote or hybrid position aligned with our site in Harrogate, North Yorkshire.
The BioMarin internship programme will enable students to gain valuable experience and knowledge of the processes and systems within BioMarin, whilst gaining an insight into the pharmaceutical/biotech industry.
About cookies on this site
We use cookies to collect and analyse information on site performance and usage, to provide social media features and to enhance and customise content and advertisements.
About cookies on this site
Cookies used on the site are categorized and below you can read about each category and allow or deny some or all of them. When categories than have been previously allowed are disabled, all cookies assigned to that category will be removed from your browser. Additionally you can see a list of cookies assigned to each category and detailed information in the cookie declaration.
Necessary cookies
Some cookies are required to provide core functionality. The website won't function properly without these cookies and they are enabled by default and cannot be disabled.
CookieHub is a Consent Management Platform (CMP) which allows users to control storage and processing of personal information.
Cloudflare is a global network designed to make everything you connect to the Internet secure, private, fast, and reliable.
Amazon Web Services offers a broad set of global cloud-based products including compute, storage, databases, analytics, networking, mobile, developer tools, management tools, IoT, security, and enterprise applications.
Microsoft Azure is a cloud computing platform offering a wide range of services, including virtual machines, databases, and AI tools.
Preferences
Preference cookies enables the web site to remember information to customize how the web site looks or behaves for each user. This may include storing selected currency, region, language or color theme.
Analytical cookies
Analytical cookies help us improve our website by collecting and reporting information on its usage.
Google Analytics is a web analytics service offered by Google that tracks and reports website traffic.
Vimeo, Inc. is an American video hosting, sharing, services provider, and broadcaster. Vimeo focuses on the delivery of high-definition video across a range of devices.
Cookies used on the site are categorized and below you can read about each category and allow or deny some or all of them. When categories than have been previously allowed are disabled, all cookies assigned to that category will be removed from your browser. Additionally you can see a list of cookies assigned to each category and detailed information in the cookie declaration.
Necessary cookies
Some cookies are required to provide core functionality. The website won't function properly without these cookies and they are enabled by default and cannot be disabled.
| Name | Hostname | Vendor | Expiry |
|---|---|---|---|
| ARRAffinity | .psiweb.org | Session | |
This cookie is set by websites run on the Windows Azure cloud platform. It is used for load balancing to make sure the visitor page requests are routed to the same server in any browsing session. | |||
| ARRAffinitySameSite | .psiweb.org | Session | |
Used to distribute traffic to the website on several servers in order to optimize response times. | |||
| __cf_bm | .vimeo.com | Cloudflare, Inc. | 1 hour |
The __cf_bm cookie supports Cloudflare Bot Management by managing incoming traffic that matches criteria associated with bots. The cookie does not collect any personal data, and any information collected is subject to one-way encryption. | |||
| _cfuvid | .vimeo.com | Session | |
Used by Cloudflare WAF to distinguish individual users who share the same IP address and apply rate limits | |||
| __cf_bm | .glueup.com | Cloudflare, Inc. | 1 hour |
The __cf_bm cookie supports Cloudflare Bot Management by managing incoming traffic that matches criteria associated with bots. The cookie does not collect any personal data, and any information collected is subject to one-way encryption. | |||
| AWSALBTGCORS | psi.glueup.com | 7 days | |
AWS Classic Load Balancer Cookie: Load Balancing Cookie: Used to map the session to the instance. Same value as AWSELB. | |||
| PHPSESSID | psi.glueup.com | Session | |
Cookie generated by applications based on the PHP language. This is a general purpose identifier used to maintain user session variables. It is normally a random generated number, how it is used can be specific to the site, but a good example is maintaining a logged-in status for a user between pages. | |||
| History.store | Session | ||
| cookiehub | .psiweb.org | CookieHub | 365 days |
Used by CookieHub to store information about whether visitors have given or declined the use of cookie categories used on the site. | |||
Preferences
Preference cookies enables the web site to remember information to customize how the web site looks or behaves for each user. This may include storing selected currency, region, language or color theme.
| Name | Hostname | Vendor | Expiry |
|---|---|---|---|
| vuid | .vimeo.com | 400 days | |
These cookies are used by the Vimeo video player on websites. | |||
| AWSALBCORS | psi.glueup.com | 7 days | |
Amazon Web Services cookie. This cookie enables us to allocate server traffic to make the user experience as smooth as possible. A so-called load balancer is used to determine which server currently has the best availability. The information generated cannot identify you as an individual. | |||
Analytical cookies
Analytical cookies help us improve our website by collecting and reporting information on its usage.
| Name | Hostname | Vendor | Expiry |
|---|---|---|---|
| _ga_ | .psiweb.org | 400 days | |
Contains a unique identifier used by Google Analytics 4 to determine that two distinct hits belong to the same user across browsing sessions. | |||
| _ga | .psiweb.org | 400 days | |
Contains a unique identifier used by Google Analytics to determine that two distinct hits belong to the same user across browsing sessions. | |||
