In this webinar, the EU regulatory and Industry members of the ICH E9(R1) working group will present the new draft addendum for ICH E9 on estimands and sensitivity analysis. The addendum introduces a new framework for designing and analysing clinical trials aligned to the trial objectives.
Rob Hemmings (MHRA) will present the motivation behind the new draft addendum, define estimands and sensitivity analysis, and explain different strategies that can be used in constructing an estimand.
Frank Bretz (Novartis) will present case studies to illustrate how the new framework can be implemented in designing clinical trials and defining the appropriate analysis methods.
A Q&A session will be chaired by Frank Pétavy (EMA) and Chrissie Fletcher (Amgen).
In this webinar, the EU regulatory and Industry members of the ICH E9(R1) working group will present the new draft addendum for ICH E9 on estimands and sensitivity analysis. The addendum introduces a new framework for designing and analysing clinical trials aligned to the trial objectives.
Rob Hemmings (MHRA) will present the motivation behind the new draft addendum, define estimands and sensitivity analysis, and explain different strategies that can be used in constructing an estimand.
Frank Bretz (Novartis) will present case studies to illustrate how the new framework can be implemented in designing clinical trials and defining the appropriate analysis methods.
A Q&A session will be chaired by Frank Pétavy (EMA) and Chrissie Fletcher (Amgen).
In this webinar, the EU regulatory and Industry members of the ICH E9(R1) working group will present the new draft addendum for ICH E9 on estimands and sensitivity analysis. The addendum introduces a new framework for designing and analysing clinical trials aligned to the trial objectives.
Rob Hemmings (MHRA) will present the motivation behind the new draft addendum, define estimands and sensitivity analysis, and explain different strategies that can be used in constructing an estimand.
Frank Bretz (Novartis) will present case studies to illustrate how the new framework can be implemented in designing clinical trials and defining the appropriate analysis methods.
A Q&A session will be chaired by Frank Pétavy (EMA) and Chrissie Fletcher (Amgen).
In this webinar, the EU regulatory and Industry members of the ICH E9(R1) working group will present the new draft addendum for ICH E9 on estimands and sensitivity analysis. The addendum introduces a new framework for designing and analysing clinical trials aligned to the trial objectives.
Rob Hemmings (MHRA) will present the motivation behind the new draft addendum, define estimands and sensitivity analysis, and explain different strategies that can be used in constructing an estimand.
Frank Bretz (Novartis) will present case studies to illustrate how the new framework can be implemented in designing clinical trials and defining the appropriate analysis methods.
A Q&A session will be chaired by Frank Pétavy (EMA) and Chrissie Fletcher (Amgen).
In this webinar, the EU regulatory and Industry members of the ICH E9(R1) working group will present the new draft addendum for ICH E9 on estimands and sensitivity analysis. The addendum introduces a new framework for designing and analysing clinical trials aligned to the trial objectives.
Rob Hemmings (MHRA) will present the motivation behind the new draft addendum, define estimands and sensitivity analysis, and explain different strategies that can be used in constructing an estimand.
Frank Bretz (Novartis) will present case studies to illustrate how the new framework can be implemented in designing clinical trials and defining the appropriate analysis methods.
A Q&A session will be chaired by Frank Pétavy (EMA) and Chrissie Fletcher (Amgen).
In this webinar, the EU regulatory and Industry members of the ICH E9(R1) working group will present the new draft addendum for ICH E9 on estimands and sensitivity analysis. The addendum introduces a new framework for designing and analysing clinical trials aligned to the trial objectives.
Rob Hemmings (MHRA) will present the motivation behind the new draft addendum, define estimands and sensitivity analysis, and explain different strategies that can be used in constructing an estimand.
Frank Bretz (Novartis) will present case studies to illustrate how the new framework can be implemented in designing clinical trials and defining the appropriate analysis methods.
A Q&A session will be chaired by Frank Pétavy (EMA) and Chrissie Fletcher (Amgen).
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: Development of Gene Therapies: Strategic, Scientific, Regulatory and Access Considerations
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.
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 Training Course: Regulatory Guidelines for Statisticians
This 2-day course is designed to provide a comprehensive understanding of the regulatory guidelines affecting statisticians in the pharmaceutical industry, including the latest updates in the field. The course will cover key International Council for Harmonisation (ICH) guidelines and other key regional regulatory agency documents.
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.
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 apprenticeship role offers a unique opportunity to learn and work in a global healthcare consultancy company alongside a team of statisticians, psychometricians and programmers.
Statisticians in the Pharmaceutical Industry Executive Office: c/o MCI UK Ltd | Unit 24/22 South | Building 4000 | Langstone Park| Langstone Road | Havant | PO9 1SA | UK