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 A Hands-On Workshop: Advanced Simcyp Designer for Tailored Biologics PBPK-PD/QSP Modelling This advanced hands-on workshop builds upon foundational knowledge of biologics PBPK modelling and guides you through the creation and extension of large molecule models using Simcyp Simulator’s biologics module and Simcyp Designer’s biologics platform. Participants will engage in hands-on exercises to build and refine models for monoclonal antibodies and other biologics, integrating mechanistic PK, complex distribution processes, and downstream PD/QSP components. This workshop focuses on applying Simcyp Designer to rapidly prototype and iterate advanced biologics models, with emphasis on building reusable components and tailoring models to fit specific mechanisms, data, or hypotheses. Lectures and tutorials are informed by a published biologics PBPK tutorial (Link), extended with new case studies and model structures. Prerequisites: Basic biologics PBPK modelling knowledge 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: Monday10th November 3-6pm (UK time) Tuesday11th November 3-6pm (UK time) Wednesday 12th November 3-6pm (UK time) Thursday 13th November 3-6pm (UK time) Friday 14th November 3-5pm (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 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

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 disease populations. Read more

July 13-17, 2026 | ONLINE Parameter Estimation and Pharmacodynamics (PE/PD) A systems pharmacology approach to modeling and simulation—accelerating model building and covariate recognition in drug development by combining top-down and bottom-up PBPK modeling of pharmacokinetics linked to drug response. The workshop covers the concepts and the practical applications of integrating in vitro data and physiological knowledge with clinical observations for the purpose of estimating unknown/uncertain model parameters. Delegates will work through different parameter estimation examples using fitting tools and explore various PD models. 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