Model-informed Drug Development Intensive Interactive Courses

June 8-12, 2026 | ONLINE From Discovery to First-in-human (FIH) Using IVIVE-PBPK Modeling In this focused workshop you will use the dynamic models within the Simcyp Discovery Simulator to prioritise compounds for progress to the next stage of development using information available in early drug discovery. You will use information on clearance, absorption, tissue distribution and DDI liability to inform compound selection. Finally, from the originally large database, only a few compounds will be selected for FIH and the simulation results compared with available clinical data. The case studies will cover various elements of model development including absorption, distribution and elimination. 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 have some familiarity 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 8-12, 2026 | ONLINE Simcyp Designer (June 2026)  This course will review the principles of PBPK modelling, using the Simcyp Simulator and how to use Simcyp Designer to modify existing PBPK models and link them to custom-built PD/QSP models. We will have brief lectures to introduce the PBPK models to be changed and interactive hands-on sessions to introduce the customisation of PBPK models with Simcyp Designer. No prior knowledge is required. Access to the Simcyp Simulator and Simcyp Designer will be provided. The workshop is hands-on intensive, and joining the live online sessions is recommended.  Access to the Simcyp Simulator and Simcyp Designer will be provided.  Course Cost £1450 (3 Points for Consortium Members) This course will run via Teams: Monday 8th June 2-5pm (UK time) Tuesday 9th June 2-5pm (UK time) Wednesday 10th June 2-5pm (UK time) Thursday 11th June 2-5pm (UK time) Friday 12th June 2-5pm (UK time) 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 15-19, 2026 | ONLINE Mechanistic oral absorption modelling and prediction of bioavailability for drug products incorporating inter-subject variability. Theory and applications of the Simcyp Advanced Dissolution, Absorption, and Metabolism (ADAM) Model. Gut wall permeability and first-pass metabolism Drug solubility, dissolution, precipitation and supersaturation Oral drug absorption incorporating food effects Bioavailability and the impact of physiology and dosage form including salts Entero-hepatic recirculation Inter-individual variability assessment Application of the SIVA Toolkit to the modeling of in vitro experiments to confirm and/or estimate parameters for PBPK simulations with a case study; mechanistic modeling of dissolution and precipitation in USP 2, USP 4, serial dilution, transfer and biphasic systems. 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

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