The webinar will provide a general introduction to the topic of combining sexes for statistical analysis in Toxicology. It will also discuss guideline recommendations pertaining to this topic.

Since the introductio of ICH-E6 R2 Addendum sponsors must introduce formal Quality Risk Management and define Quality Tolerance Limits to their clnical development programs. This webinar will cover an introduction to those concepts, recent developments and examples of how companies are defining QTL's in practice.

Do you want to learn more about innovative approaches for the development of pediatric medicines? Then join this PSI webinar on December 8. We have organized an exciting webinar with very knowledgeable speakers who will share their thoughts, ideas and experiences, including case studies, on a range of issues relating to historical data, Bayesian methodology, and partial and full extrapolation approaches in the context of developing pediatric medicines.

Statistical Observations on SARS-CoV-2 & Crisis Vaccine Clinical Testing. Scott Patterson, Bo Fu, Ya Meng, Fabrice Bailleux, Josh Chen.

Bringing estimands to life through a real case study. Members of the estimands Implementation Working Group (EIWG) will describe the background and study objectives, intercurrent events of interest and chosen estimands in the PIONEER study.