Model-informed Drug Development Intensive Interactive Courses

September 29 - 3 October, 2025 | ONLINE Predicting and evaluating complex DDIs—application of the Simcyp Population-based Simulator to real-life cases. 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

Certara UK Limited is running a Simcyp hands-on workshop discussing the changes to pharmacokinetics during pregnancy and the prediction of pharmacokinetics (including in the milk) during lactation. Population based Physiologically Based Pharmacokinetic (PBPK) approach will be utilized to describe the pharmacokinetics during pregnancy and lactation and to determine population variability. The major topics covered are: Maternal and fetal gestational age-dependent physiological changes Prediction of maternal and fetal drug pharmacokinetics Ways of incorporating ex vivo experimental data on transplacental kinetics within the PBPK model Handling gestational age-varying covariates during simulation Prediction of PK in breastfeeding mothers and milk exposure using lactation models Prediction of infant dose for breastfed infant This course will be run using the Amazon Workspaces in Cloud; please ensure you have access to a computer. 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 Workshop will take place in Princeton NJ November 17-21, 2025 VENUE: HYATT REGENCY PRINCETON, 102 Carnegie Center,  Princeton, NJ 08540, US 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  COURSE COST:  £3,900          January to 8th July £4,700          9th July to 9th October £5,600          10th October to 10th November Incorporating population variability into mechanistic prediction of PK and modeling PK/PD The model-informed approach to various aspects of drug development is rapidly being adopted by the leading pharmaceutical companies. The Simcyp workshops focus on the optimal use of compound-specific in vitro and in vivo data together with system specific information related to humans to simulate and understand drug behavior in various target populations. This integrated approach informs decisions related to Investigational New Drugs and assists with the conduct and optimal design of clinical studies. The ultimate aim is to better understand drug PK/PD properties, reduce the cost and time of drug development, improve the quality of regulatory submissions, and eventually implement precision medicine. Read more

November 3-7, 2025 | ONLINE Predicting age related changes to pharmacokinetics (PK) and drug-drug interactions including associated variability—linking this information to drug response in the pediatric population. Participants will learn how PK behavior can be modeled in preterm and term neonates, infants, and children and how it can be linked to predict the drug response (PD) within the PBPK platform. Hands-on exercises explore how this valuable information is relevant to early and informed decisions to assist in the improved design of pediatric clinical 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

November 10-14, 2025 | 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 £1350 (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

November 17-21, 2025 | ONLINE The ABC of modelling drug transporter data: Mechanistic approaches to predict the impact of drug transport proteins on ADME, Pharmacokinetics, and Toxicity Overview: This course provides a dynamic mixture of lectures, demonstrations and hands-on exercises providing a wide-array of theory and practical know how. Live demonstrations of the simulation platforms essential for consideration in developing PBPK models with transporters are given, which will facilitate the attendees learning, driven through hands-on sessions to be attempted remotely. The hands-on sessions will be re-visited the following day with the tutors providing guidance, troubleshooting tips and facilitating interactive Q&A on the exercises. 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