On June 12th, 2023, the CIOMS (Council for International Organizations of Medical Sciences) Working Group XII1 published a draft guideline on Benefit-Risk Balance for Medicinal Products for Public Consultation, which the BRESIG took the opportunity to review. We successfully submitted our feedback by the deadline of July 24th, 2023.
The long-awaited guideline is close to the BRESIG’s heart as it covers a variety of topics discussed within the group, and is central to our work within the (bio-)pharmaceutical industry. CIOMS guidelines are often cited and form the basis of many ICH (International Council for Harmonisation) guidelines.2
We are looking very much forward to finalization of this guideline because it provides an excellent overview of the elements of benefit-risk assessment that have been discussed in recent years in the literature and among practitioners. Therefore it is a perfect read for people newly interested but also for those following up on the topic. Notably valuable is a section including case studies.
[1] https://cioms.ch/working-groups/working-group-xii/
[2] https://cioms.ch/cioms-guidelines-served-basis-many-ich-guidelines/
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 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 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.
