Model-informed Drug Development Intensive Interactive Courses

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

A Hands-On Workshop with Simcyp Designer for Tailored PBPK-PD/QSP Models June 2, 2025 | IN PERSON, Thessaloniki, Greece Would you like to modify and tailor population PBPK models? This course will review the principles of PBPK modelling, using the Simcyp Simulator and how to use Simcyp Designer to modify existing PBPK models with your own extension and link them to custom-built PD/QSP models. We will have lectures to introduce the PBPK models to be changed and have hands-on exercises to train the customisation of PBPK models with the Designer. No prior knowledge is required. Access to the Simcyp Simulator and Simcyp Designer will be provided. Participant are required to bring their own laptops as the workshop is hands-on intensive. Read more

This workshop will explain the principle of therapeutic protein pharmacokinetic and pharmacodynamic 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 21-24 2025 | 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 V24 including active license Monday 21 July - Introduction to IVIVE linked PBPK modelling Tuesday 22 July - Incorporation of physiological variability in prediction of PK profiles Wednesday 23 July - PBPK modelling to predict drug-drug interactions (enzymes and transporters) Thursday 24 July - Office hour / Question & Answer Session Read more

August 4-5, 2025 |  Tokyo, Japan VENUE: TKP Garden City PREMIUM Shinagawa Takanawa 4th Floor​ 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. 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. Read more

Simcyp Focused Workshop: Best Practice, August 6-7, 2025 | Tokyo, Japan VENUE: TKP Garden City PREMIUM Shinagawa Takanawa 4th Floor​ 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. 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. Read more