The Regulatory European Special Interest Group (ESIG) is probably the longest serving ESIG, although it was predominantly referred to as a committee until the end of 2020. We have a total of 20 members from 8 countries and 17 companies, and our purpose is to co-ordinate regulatory activities across the European Pharmaceutical Statistical community and to engage with European Regulatory statisticians (here is the link to our page). It is probably fair to say that the COVID-19 pandemic has stretched out colleagues in Regulatory Agencies, and as a result we have seen fewer regulatory guidelines being issued (as either draft or final). This has not reduced our activities, though, and here are some key ones coming up:
Jointly with the Biopharmaceutical Section of the American Statistical Association (ASA) we are jointly organising a webinar on Complex Innovative Designs (CID) in practice. This will be held on 21 October (14.00 – 16.00 BST), with speakers from the FDA, Novartis and GSK. If you are interested, then please find further information and a link to the registration page here.
We typically meet annually with both the MHRA statisticians and the EMA Biostatistics Working Party for an exchange of statistical topics important for both regulators and industry. The EMA has scheduled this again for 29 October and asked us and other statistical stakeholder organisations for topics. We indicated that we would like to discuss the Danish Data Analytics Center and the future plans of BSWP to analyse data, decentralised trials and the use of historical / synthetic control arm data, but have not received any further information yet on the agenda of the meeting. We will feed back on this meeting afterwards.
Finally, several of our members were on the scientific and organisational committee for the 6th EFSPI Regulatory Statistics Workshop held online between 13 and 15 September, covering decentralised trials, complex innovative designs and real world data. We hope many of you were amongst the >1000 registered attendees and enjoyed the event.
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.
