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ESIG of the Month - August 2021

Sep 8, 2021, 09:35 AM

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.

Upcoming Events

PSI Medical Statistics Careers Event

This event is aimed at students with an interest in the field of Medical Statistics, for example within pharmaceuticals, healthcare and/or medical research.

PSI Career Young Virtual Meet (Q4 2023)

This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.

PSI Webinar(s): Causal inference in Clinical Trials

Over the course of two sessions, a panel of 8 esteemed speakers will give an introduction to the topic, followed by a presentation of case studies & interactive panel discussion.

PSI HTA SIG Webinar: Estimands, PICOs and Co. - Are we losing or gaining in translation?

Over the past years, areas of clinical development and patient access / health technology assessment (HTA) have moved closer together. However, both areas differ in how they approach their respective research or policy questions. While the estimand framework is being the focus in clinical development, HTA is being viewed through the lens of the PICO framework. This webinar brings together Antonio Remiro-Azocar, Robert Hemmings and Nicholas Latimer, who are renowned experts in the respective fields. They will provide an introduction to these three concepts, illustrated with examples.

PSI Careers Lunch & Learn: Is it AI? Can you spot the fake?

In a world buzzing with artificial intelligence, can you distinguish between what's AI-generated and what's not? The session promises to showcase machine-generated content, challenging your perceptions, and luring you into the fascinating world of AI technology.

PSI VisSIG Wonderful Wednesday Webinar Series (2023)

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.

PSI Training Course: R for Clinical Trial Statisticians

This course consists of 5 x 2 hour training sessions run over 5 weeks. For those who cannot attend the date and time provided, there will be a recording provided and a follow-up 1 hour Q and A session. Participation will provide access to extensive course materials in the form of a “bookdown” site. However, this is designed as a hands-on, interactive course. Both you and the trainers will work entirely within the RStudio Cloud development environment, which will remain accessible between virtual sessions in order to further explore and cement your understanding.

PSI Pre-Clinical SIG Workshop

The Pre-Clinical SIG Workshop returns for 2024, bringing you a two half-days event, starting with a course on pre-clinical design of experiments. We will also have speakers on topics such as statistics and genetic toxicology, the new and promising OMARS DOE and ANOVA-type.

PSI Mentoring 2024

Are you a member of PSI looking to further your career or help develop others - why not sign up to the PSI Mentoring scheme? You can expand your network, improve your leadership skills and learn from more senior colleagues in the industry.

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