Provide a platform for statisticians from sponsors and CROs to working in the launch and lifecycle management (including traditional medical affairs area, commercialization, HTA (in collaboration with the respective ESIG)) and new evolving areas) to help each other in areas of pre-competitive collaboration.
Shape the industry to increase the influence of statisticians in launch and lifecycle and show how good looks like for the work of statisticians e.g. through case studies.
Drive scientific projects and innovation forward related to the field of Launch and Lifecycle.
Create a homepage for external communication
Collect case studies of how good looks like
Publish manuscripts in journals and communicate via other channels about:
The role statisticians do and can play in medical affairs and their imapct.
Innovative designs in medical affairs.
Use of registries in medical affairs.
Use of historical data in medical affairs.
Implementation of pragmatic studies in medical affairs.
Organize workshops and conference sessions around the topics mentioned above.
Public relation activities to show how statisticians and adata can help make better decisions.
Collaboration with non-statistical associations (e.g. medical) working in the field to improve the role of statistics.
Develop best practices for statisticians to be successful and efficent (evidence dissemination and resources, planning and strategic thinking.)
Jenny Devenport (Roche) (Co-Chair)
Yulia Dyachkova (Merck) (Co-Chair)
Alexander Schacht
Anny Stari
Bob Shaw
Cornelia Dunger-Baldauf
Daniel Saure
David Lawrence
Frank Langer
Gbenga Kazeem
Imi Faghmous
Knut Richert
Lucy DeCosta
Martin Blogg
Pierre Mancini
Stefan Franzen
Slides from PSI Annual Conference 2022
Poster from EFSPI Regulatory Conference 2022
Contact Jenny Devenport or Yulia Dyachkova
This course is aimed at clinical trial statisticians who are new to or with limited experience of machine learning. Attendees will learn about a range of topics in machine learning, including practical sessions in R.
This webinar will explore two different approaches to Correlates of Protection in vaccine development.
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 event will open with an overview on drug development in women’s health from a clinician perspective. This talk is followed by talks about statistical challenges when planning IVF studies and analysing the menstrual cycles.
This webinar will provide an overview of surrogacy for licensing and reimbursement. In turn, the need of extensions of the SPIRIT and CONSORT statement will be defined and outlined, with case studies to support.
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.
We will share a brief overview of what Mobilise D is and why it is an important step stone in the development of digital biomarkers, and how Mobilise D outputs can be relevant for you.
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 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 networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
We have exciting new opportunities available for Study Statisticians, Support Statisticians and Exploratory Statisticians at various levels.
