PSI Scientific Committee Webinar: Statistical Challenges in Analytical Comparability and Biosimilarity Assessment

PSI Training Course: Introduction to Machine Learning

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.

Joint PSI/EFSPI Vaccine SIG Webinar: Statistical and Mechanistic Models for Correlates of Protection

This webinar will explore two different approaches to Correlates of Protection in vaccine development.

Joint PSI/EFSPI Visualisation SIG 'Wonderful Wednesday' Webinars

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 Webinar: Drug Development in Women's Health

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.

PSI Webinar: Surrogacy

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.

Joint PSI/EFSPI Pre-Clinical SIG Webinar: Virtual Control Groups in Toxicity Studies

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.

Joint PSI/EFSPI Data Science SIG Webinar: Developing Digital Measures (Digital Biomarkers) in Drug Development – insights from Mobilise D consortium

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.

PSI Career Young Virtual Event (Q2 2024)

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 Career Young Virtual Event (Q3 2024)

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 Introduction to Industry Training (ITIT) Course - 2024/2025

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.

PSI Career Young Virtual Event (Q4 2024)

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

Thomas Lang (EMA BSWP / AGES)	Thomas Lang is biostatistician by training. He spent eight years in academic research, followed by three years in clinical research in the pharmaceutical industry. He currently works as senior statistical assessor for the Austrian Agency for Health and Food Safety. For more than nine years he was a member of the Scientific Advice Working Party at EMA. In his current role of a member of the Biostatistics Working Party Thomas acted as rapporteur for the EMA Reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development.
Bruno Boulanger (Pharmalex)	Bruno has 25 years of experience in several areas of pharmaceutical research and industry including discovery, toxicology, CMC and early clinical phases. He holds various positions in Europe and in USA. Bruno joined UCB Pharma in 2007 as Director of Exploratory Statistics. Bruno is also since 2000 Lecturer at the Université of Liège, in the School of Pharmacy, teaching Design of Experiments and Statistics. He is also a USP Expert, member of the Committee of Experts in Statistics since 2010. Bruno has authored or co-authored more than 100 publications in applied statistics.
Johanna Mielke (Bayer)	Johanna studied Statistics at TU Dortmund University (Germany). Afterwards, she joined the Statistical Methodology Group at Novartis in Basel (Switzerland) as a Doctoral Candidate. Her research was focussed on the development of statistical methodologies for clinical biosimilar development. After completing her Ph.D. in 2018, Johanna started to work as a Data Scientist at Bayer in Wuppertal (Germany).

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