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 aim of this focused workshop is to demonstrate the application of best practices in developing PBPK models, and to show how to verify and refine model performance. Various case studies, including real-life examples, will be presented. The case studies will cover key elements of model development, including DDIs, specific populations, transporters, and different formulations. Optimal in vitro and clinical datasets will be discussed. Participants will learn how to select the most suitable models and evaluate the impact of relevant assumptions on model performance. Requirements for regulatory submissions will also be discussed. This is an intermediate-level workshop intended for participants with a basic understanding of PBPK modelling and some prior hands-on experience. 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

PBPK in specific populations This workshop will provide an in-depth overview of generating populations for mechanistic PBPK, focusing on key covariates to inform prediction of PK in healthy as well as ethnic and disease populations. Read more

July 13-17, 2026 | ONLINE Bridging Bottom-Up and Top-Down PBPK Approaches: Sensitivity Analysis and UQ for Regulatory Applications The recent ICH M15 Model-Informed Drug Development (MIDD) guidance outlines regulatory expectations for the development, evaluation, and application of mechanistic models. This workshop focuses on PBPK model development and performance assessment, with particular emphasis on sensitivity analysis, parameter estimation, and uncertainty quantification (UQ) in a regulatory context. Participants will learn how sensitivity analysis can support model development, identify influential parameters, and inform confidence in model predictions. Key principles and practical implementation of uncertainty quantification will be introduced as part of PBPK model evaluation, alongside strategies for bridging bottom-up and top-down. The workshop demonstrates how in vitro data, physiological knowledge, and clinical observations can be integrated to refine uncertain model parameters. Delegates will explore sensitivity analysis tools, parameter estimation workflows using clinical data, and the use of the Simcyp-R package for running simulations and analyzing model outputs in R. An overview of pharmacodynamic models available within the Simulator will also be provided, illustrating their integration with PBPK modeling. The course is delivered as through a combination of lectures and tutor led interactive examples sessions. 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

July 13-17, 2026 | ONLINE This workshop will explain the principle of therapeutic protein pharmacokinetic (PK) and pharmacodynamic (PD) modelling. Distribution, clearance, FcRn recycling, target-mediated drug disposition (TMDD), and subcutaneous absorption will be covered for monoclonal antibodies and other therapeutic proteins. Additionally, the suppression of CYP enzymes by cytokines and thus interactions between biologics and small molecule drugs will be simulated. Participants will learn how to apply these models using case studies. 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

***This Course is only open to SIMCYP ACADEMIC RESEARCH LICENSE HOLDERS*** Simcyp Intensive 4-day PBPK Boot Camp for Students, July 20-23, 2026 | ONLINE  This PBPK boot camp is an ideal way to enhance the continuous education of students conducting research in the areas of Discovery, Drug Metabolism and Pharmacokinetics (DMPK), Clinical Pharmacology, Pharmaceutical and Drug Development and, it will provide an excellent opportunity to develop skills and remain informed of the latest scientific advances using Simcyp Simulator as the state of the art PBPK modelling platform. This 4-day workshop will comprise of lectures delivered by leading experts in the fields of PBPK modelling and will cover some of the major topics in model-informed drug development in-depth. you will need:   a functional Simcyp Simulator V25 including active license Monday 20 July - Introduction to IVIVE linked PBPK modelling Tuesday 21 July - Incorporation of physiological variability in prediction of PK profiles Wednesday 22 July - PBPK modelling to predict drug-drug interactions (enzymes and transporters) Thursday 23 July - Office hour / Question & Answer Session Read more

Predicting and evaluating complex DDIs—application of the Simcyp Population-based Simulator to real-life cases. August 3-4, 2026 |  Tokyo, Japan VENUE: TKP Garden City PREMIUM Shinagawa Takanawa 4F LAPTOP: Delegates are required to bring a laptop computer, and will be provided with access to the Simcyp Simulator via Amazon Workspaces for the duration of the course.  COURSE MATERIAL: will be provided electronically via LearnUpon. No printed materials will be given out during the course. Read more