Model-informed Drug Development Intensive Interactive Courses

October 19-30, 2026 | ONLINE Live sessions typically run for 3hrs per day via Teams with assignments to complete out of session. 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. 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 2-6, 2026 | 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 2-6, 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: Monday 2nd November 3-6pm (UK time) Tuesday 3rd November 3-6pm (UK time) Wednesday 4th November 3-6pm (UK time) Thursday 5th November 3-6pm (UK time) Friday 6th 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 16-20, 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

November 16-20, 2025 | ONLINE This course broadens the range and utilization of in silico-based mechanistic prediction and analysis of drug absorption after oral delivery, including the development of mechanistic physiologically based in vitro-in vivo correlations (IVIVCs), virtual bioequivalence (VBE) concepts, and application of biopharmaceutic IVIVE using the SIVA Toolkit.  We strongly recommend attending Oral Absorption I before taking this workshop. Read more

Clinical Applications of Endogenous Biomarkers using PBPK  Tutors: Matt Harwood, Aneesh Karkhanis, Jakub Witkowski, Xian Pa Date: November 16-20, 2026 | ONLINE Time: 15:00-18:00 Daily (UK time)  Number of participants: Minimum 6 / Maximum 40  Course Title: A Hands-On Workshop to explore the clinical applications of Endogenous Biomarkers using PBPK  This course provides a mixture of lectures, demonstrations, and hands-on exercises focusing on clinical applications of endogenous biomarkers using PBPK models. Details of model development and assumptions along with model verification and application will be described. Attendees will be able to view ‘live’ lectures, simulator demonstrations and gain access to the Simcyp simulator to undertake guided hands-on exercises, facilitate recognising the core aspects of endogenous molecule modelling within PBPK. The hands-on exercises will be provided to reinforce the presented concepts.  This workshop particularly lends itself to individuals keen to explore the development and clinical/regulatory applications of endogenous molecule PBPK models that are sensitive, specific and selective markers of ADME-related enzymes and transporters. Attendees will explore the role of PBPK biomarker models to evaluate the potential risk of metabolic and transporter-mediated DDI risk, while the practical advantages of employing biomarkers as a tool to refine the PBPK model for application in disease states are presented. The utility of the simulator to use its firmly established features available to ‘small molecule’ files for development of endogenous biomarkers are introduced, which then progresses into hands-on application of the Simulators recently incorporated endogenous module.   Read more