Model-informed Drug Development Intensive Interactive Courses

May 11-22, 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

A Hands-On Workshop with Paediatric and Pregnancy PBPK Tuesday June 2, 2026 Pharmacotherapy during pregnancy or childhood is influenced by a myriad of physiological variables that are changing dynamically. Systemic assessments of the influence of these covariates are challenging and depend on drugs and physiological attributes and their interaction but have been made easier with the utilization of the physiologically based pharmacokinetic (PBPK) approach. The objective of this workshop is to demonstrate the application of PBPK approach to predict pharmacokinetics before, during, and after pregnancy as well as in neonates. Read more

June 2, 2026 Dubrovnik - Croatia QSP has become an established component of modern regulatory submissions, with hundreds of FDA and EMA filings supported by mechanistic models. Yet despite demonstrated ROI, most organizations still apply QSP selectively rather than across the broader pipeline. The primary barrier is no longer confidence in the science; it’s enabling teams to use QSP efficiently, repeatedly, and at scale. This workshop will focus on how Certara IQ™ creates a practical environment for doing exactly that, blending instruction with hands-on guided exercises.  The session is structured for a mixed audience, from early-career modelers looking to learn practical workflows, to senior scientists and decision-makers interested in how scalable QSP tooling supports feasibility evaluation, differentiation, dose selection, and program decision-making. After a concise framing of the scaling challenge, participants will work through real examples, using IQ to answer four high-value development questions:  ·        New target feasibility in early discovery   ·        Best-in-class property assessment and competitor landscape modeling   ·        First-in-human dose projection with uncertainty characterization   ·        Recommended Phase 2 dose selection with Virtual Populations  Each section will pair a case study with interactive use of the platform. Attendees will gain experience navigating workflows, exploring assumptions, and generating analyses suitable for communication with governance teams.  By the end of the workshop, participants will have worked through full end-to-end examples themselves, and see how scalable QSP tooling can expand the number of programs supported, shorten turnaround time, and make model-based decisions more repeatable. The goal is for attendees to leave with a clear understanding of how these capabilities translate into broader impact within their own organizations.  Who Should Attend   Anyone looking for hands-on engagement with a QSP modeling platform, including (but not limited to):   Modelers (QSP, translational PKPD, DMPK)   Clinical pharmacology (Quantitative Pharmacology)   Project leads, R&D heads   Important Notes  This is an in-person, hands-on workshop.  All participants must bring their own laptop for the hands-on components of the workshop.  You will receive confirmation from the event organizer once your registration is received.  You will receive a separate email prior to the workshop regarding the software license and logging in instructions.  Refreshments, beverages, and lunch will be provided.  Read more

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 3-6pm (UK time) Tuesday 9th June 3-6pm (UK time) Wednesday 10th June 3-6pm (UK time) Thursday 11th June 3-6pm (UK time) Friday 12th June 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