Model-informed Drug Development Intensive Interactive Courses

Simcyp Focused Workshop: Best Practice, June 16-20, 2025 | ONLINE It is assumed that the participants are familiar with the fundamentals of PBPK modeling and have hands-on experience. The main aim of this focused workshop is to demonstrate the application of best practices in developing PBPK models, and to indicate how to qualify and refine model performance. Various case studies, including some real-life examples, will be presented. The case studies will cover various elements of model development including DDIs, special populations, transporters, and different formulations. Optimal in vitro and clinical data sets will be discussed. Participants will learn how to choose the most suitable models and also investigate the impact of various relevant assumptions on model performance. Requirements for regulatory submissions will also be discussed. It is assumed that the participants are familiar with the fundamentals of PBPK modeling and have hands-on experience.   Live Online Courses There are no refunds for Live Online courses.  Certara retains the right to cancel the course 30 calendar days before the first session, in which case participants will receive a full refund. Read more

June 16-20 2025 | ONLINE This workshop will provide an in depth overview of generation of populations for mechanistic PBPK, focusing on key covariates to inform prediction of pharmacokinetics in healthy as well as disease populations. Key aspects of the course: – Building populations and Correlated Monte Carlo Sampling – Age matching clinical trial design – Bridging Studies - Japanese and Chinese Populations – Mechanistically accounting for impact of Disease – Renal Impairment, Cirrhosis populations – Oncology populations Live Online Courses There are no refunds for Live Online courses.  Certara retains the right to cancel the course 30 calendar days before the first session, in which case participants will receive a full refund. Read more