Model-informed Drug Development Intensive Interactive Courses

A Short presentation from Professor Amin Rostami, Certara SVP of R&D and Chief Scientific Officer.  Read more

(004-OD) Introduction to PBPK Modelling | On-Demand Workshop Description Please note: participation is restricted to email addresses from verified organisations. This workshop introduces the core concepts and applications of In Vitro In Vivo Extrapolation (IVIVE)-linked Physiologically Based Pharmacokinetic (PBPK) modelling. You will explore how systems, drug, and trial design parameters are separated and how physiological and biological data are incorporated to predict pharmacokinetic parameters and profiles. The workshop also covers the use of PBPK models to predict transporter function and metabolism- and transporter-mediated drug-drug interactions. Course Structure The course is accessible for 30 days from the date of registration, giving you ample time to work through the material at your own pace. On successful completion, you will receive a certificate of achievement. To support active engagement, recordings and lecture slides are not available for download. Once registered, access the course via your Dashboard. Please note that each purchase covers a single seat — login credentials must not be shared. Additional seats must be purchased separately for each individual. This is a pre-recorded course from the Student Boot Camp held in July 2025. References to the Simcyp Simulator within the content are for illustrative purposes only — simulator access is not included with this on-demand course. Read more

(005-OD) Dermal | On-Demand Workshop (V25) Description This workshop focuses on the mechanistic, in silico prediction of dermal drug absorption. It covers the models used to predict skin absorption following topical application, with practical examples of mechanistic physiologically-based in vitro–in vivo correlations (IVIVCs) and virtual bioequivalence (VBE). Course Structure The course is accessible for 30 days from the date of registration. It provides approximately 7 hours of video instruction, including a practical component you can work through at your own pace. Total completion time — including hands-on exercises in the Simcyp Simulator — is estimated at 14+ hours. On successful completion, you will receive a certificate of achievement. To support active engagement, recordings and lecture slides are not available for download. Prerequisites: Delegates should be familiar with the Simcyp Simulator. Software: A temporary 4-day Simcyp Simulator licence is provided with this course, along with one office hour with an expert tutor. When you are ready to begin the practical exercises, please contact us to request your licence (allow up to 48 hours) and to arrange your office hour session. Once registered, access the course via your Dashboard. Each purchase covers a single seat — login credentials must not be shared. Additional seats must be purchased separately for each individual. Instructors: Details in the agenda. Lectures and Topics General Introduction Video 1: Introduction Dermal Absorption – Fundamentals, Skin Structure, and Model Architecture Video 2: Skin Structure and MPML MechDermA Model – General Structure and Assumptions, Part 1 Video 3: Skin Structure and MPML MechDermA Model – General Structure and Assumptions, Part 2 Mathematical Principles of the MPML MechDermA Model Video 4: MPML MechDermA Model – Compound Parameterisation Video 5: MPML MechDermA Model Outputs Accounting for Variability Across Populations Video 6: Dermal Trial Design – Multiple Application Sites Video 7: Parameterisation of Inter-Individual Variability Drug Formulation and API Absorption Video 8: In Vitro Topical Formulation Characterisation Video 9: Formulation Models and Toolbox – Solution Video 10: Formulation Models and Toolbox – Patches Video 11: How to Model Drug Metamorphosis Video 12: Dermal Absorption – Lua Scripting, Parameter Estimation and Sensitivity Analysis IVPT Module and Dermal IVIVE Video 13: Skin Permeation In Vitro Video 14: IVPT Module and Accounting for LLOQ in Simulations Video 15: IVPT Module Case Study Virtual Bioequivalence – Concepts and Applications Video 16: Virtual BE for Dermal Formulations – Concepts Video 17: Topical Product VBE Case Study Hands-On Work-Throughs MPML GUI and functionality Trial design and inter-application site correlation Role of drug formulation and API absorption IVPT module and generic membrane model IVPT and IVIVE Dermal virtual bioequivalence Read more

Mechanistic PBPK Modeling of Rectal and Vaginal Drug Absorption Advanced In Silico Predictions for Non-Oral Routes   The rectal and vaginal routes represent critical pathways in modern pharmaceutical development—yet they remain underexplored in many PBPK modeling programs. This on-demand workshop equips scientists, formulation experts, and regulatory professionals with the mechanistic knowledge and practical tools needed to predict systemic drug absorption and bioavailability for these specialized administration routes.   Who Should Enroll? Formulation scientists developing rectal suppositories, vaginal rings, or other non-oral products PBPK modelers and regulatory affairs professionals seeking specialized expertise in non-oral routes Clinical pharmacology and bioequivalence specialists supporting pediatric, women's health, or contraceptive programs Regulatory strategists building dossiers for rectal or vaginal product submissions Pharmaceutical scientists in women's health, sexual health, pediatrics, and orphan disease development Contract research organizations (CROs) offering PBPK consultancy for diverse administration routes Who Needs This Knowledge? Regulatory and Development Professionals working on: Pediatric formulations (rectal suppositories for fever, pain, and seizure management in children unable to swallow) Contraceptive and sexual health products (vaginal rings, gels, and microbicides with complex absorption profiles) Women's health therapeutics requiring vaginal delivery (hormonal therapies, antimicrobials, and long-acting formulations) Orphan and rare disease medications leveraging rectal delivery for systemic effect Drug-device combinations where formulation engineering directly impacts bioavailability Strategic Business Value Rectal Route: Bypasses hepatic first-pass metabolism for certain compounds; enables systemic delivery in pediatric, geriatric, and critically ill populations with dysphagia or GI complications Vaginal Route: Offers rich vascularization, large surface area, and reduced enzymatic activity—enabling lower doses, improved tolerability, and extended-release formulations that command premium positioning Virtual Bioequivalence (VBE): PBPK-driven VBE strategies reduce costly in vivo bioequivalence studies for generic/follow-on vaginal formulations, accelerating time-to-market Course Overview Duration: 30-day access post-registration Course Length: ~3 hours of video instruction + ~3 hours of hands-on Simcyp Simulator work Total Expected Commitment: 6+ hours What You'll Learn This workshop provides a comprehensive, case-driven exploration of mechanistic absorption modeling for non-oral routes: Rectal Absorption Module Detailed rectal physiology, histology, and implications for drug transport Classification of rectal drugs and formulation strategies (suppositories, solutions, foams, enemas) Mechanistic Rectal Absorption Model (MechRAM): structural assumptions, parameter definitions, and physiological inputs Practical parameterization techniques for leveraging in vitro dissolution, permeability, and metabolism data Real-world case study: Sodium Naproxen suppositories with sensitivity analysis on formulation attributes Vaginal Absorption Module Vaginal physiology, hormonal cycle considerations, and microbicide/contraceptive perspectives Vaginal formulation diversity (rings, gels, creams, tablets) and their mechanistic drivers Mechanistic Vaginal Absorption Model (MechVAM): model structure, design assumptions, and validation approaches Parameter estimation and optimization workflows Three distinct case studies: Dapivirine gel and ring formulations (microbicide/PrEP applications) Etonogestrel and Ethinyl Estradiol rings (contraceptive formulations with complex pharmacokinetics) Clindamycin phosphate cream (topical antimicrobial with systemic absorption) Virtual Bioequivalence (VBE) for vaginal formulations: regulatory strategy, predictive modeling, and approval pathways Hands-On Practice Four guided workshops for each route allow you to: Familiarize yourself with model structure and inputs Execute initial simulations with real case data Optimize parameters based on in vitro and clinical information Evaluate formulation impacts on systemic exposure Apply learnings to regulatory submissions and development decisions Course Structure & Access Temporary License: A 2-day Simcyp Simulator license is provided with your registration—ideal for completing all practical exercises Expert Support: One office hour with a senior Simcyp scientist (scheduled post-registration) to guide your learning and address specific questions No Downloadable Materials: Lectures and slides remain accessible within the portal for 30 days, ensuring active engagement with the content (though you may take your own notes) Single-Seat License: The course purchase is for one individual; sharing login credentials is prohibited. Additional seats must be purchased separately. Accessing Your Course: After registration, log into your Dashboard to begin immediately. You'll have 30 days to work through videos and complete assignments. Prerequisites Participants should have foundational familiarity with the Simcyp Simulator platform and basic PBPK concepts (e.g., absorption, distribution, metabolism, clearance). Prior attendance at Certara's Simcyp Introduction course or equivalent hands-on experience is recommended. Course Topics & Lectures RECTAL ABSORPTION MODEL Introduction – Clinical context and regulatory landscape Rectal Physiology Fundamentals – Anatomy, blood flow, metabolism, and implications for drug transport Rectal Drugs and Formulations – Suppositories, solutions, retention enemas, foams; formulation considerations MechRAM Structure – Model assumptions, compartments, and physiological drivers MechRAM Parametrization – Estimating input parameters from in vitro and clinical data Model Outputs and Interpretation – Plasma concentration profiles, bioavailability predictions, and sensitivity analysis Hands-On Workshops: Sodium Naproxen Suppository – Model familiarization Sodium Naproxen Suppository – Initial simulation setup and outputs Sodium Naproxen Suppository – Parameter optimization and sensitivity analysis Impact of in vitro drug release data on systemic exposure predictions VAGINAL ABSORPTION MODEL Introduction to MechVAM – Vaginal route significance in women's health and sexual health Vaginal Physiology Fundamentals – Anatomy, tissue composition, blood flow, microbicide/hormone considerations Vaginal Drugs and Formulations – Rings (contraceptive, long-acting), gels, creams, tablets; formulation science MechVAM Model Structure – Compartmentalization, physiological assumptions, and formulation interactions MechVAM Parametrization – Building predictive models from dissolution, permeability, and clinical data Model Outputs and Interpretation – Plasma and local vaginal concentrations, bioequivalence predictions Hands-On Workshops: Dapivirine Gel and Ring Formulations – Microbicide absorption and systemic exposure Etonogestrel and Ethinyl Estradiol Rings – Contraceptive formulation complexity Clindamycin Phosphate Cream – Topical antimicrobial with systemic absorption Virtual Bioequivalence for Vaginal Formulations – Regulatory strategy and case study Next Steps Register today to access this advanced workshop for 30 days. Upon registration: Log into your Dashboard to begin video modules immediately Review the course material at your own pace Contact Certara to request your temporary Simcyp license (allow up to 48 hours) Schedule your expert office hour to optimize your learning experience Complete hands-on assignments and earn your certificateYour Instructors This workshop is led by world-class scientists from Certara's Simcyp division, each bringing deep expertise in non-oral drug delivery and mechanistic modeling Your Instructors This workshop is led by world-class scientists from Certara's Simcyp division, each bringing deep expertise in non-oral drug delivery and mechanistic modeling Read more

This workshop introduces the ocular modelling feature first introduced in Version 23 of the Simcyp Simulator. No advanced Simcyp experience is required, though some prior knowledge of PBPK modelling is helpful. The course provides a structured overview of the ocular model, including the pathways compounds are expected to follow based on their physicochemical properties. Common dosing strategies — topical application and intravitreal injection — are covered in detail, along with the application of controlled release profiles for both routes. Given the large number of parameters the model requires, dedicated time is spent discussing experimental data availability, Simcyp-based predictions, and practical approaches for handling parameters that remain unknown. Hands-on examples are included throughout to build confidence and familiarity with the module. Course Structure The course is accessible for 30 days from the date of registration. It provides approximately 2 hours of video instruction plus around 1 hour of hands-on Simcyp Simulator work, with a total expected commitment of 3+ hours. On successful completion, you will receive a certificate of achievement. A 2-day Simcyp Simulator licence is included with your registration, providing sufficient access to complete all practical exercises. One office hour with a senior Simcyp scientist is also included and can be scheduled after registration to support your learning and address specific questions. Lectures and slides remain accessible within the portal for the full 30-day period. Recordings and materials are not available for download, though you are welcome to take your own notes. Each purchase covers a single seat — login credentials must not be shared. Additional seats must be purchased separately for each individual. Once registered, log into your Dashboard to begin immediately. Session Outline 18 min        Lecture 1: Background, motivation and model overview 32 min        Lecture 2: Population parameters 10 min        Lecture 3: Compound parameters 10 min        Lecture 4: Elimination 22 min        Lecture 5: Topical dosing 15 min        Lecture 6: Intravitreal injections 13 min        Lecture 7: Parameters and predictions Your Instructors This workshop is led by world-class scientists from Certara's Simcyp division, each bringing deep expertise in non-oral drug delivery and mechanistic modeling Read more

Long-Acting Injectables Focused On Demand Workshop  Accelerate your long-acting injectable (LAI) development programme with hands-on, expert-led modelling training. Learn how to develop in vitro release and in vivo pharmacokinetic (PK) models using the long-acting injectable module of Simcyp Simulator for PLGA-based implants and in vivo PK models for suspension formulations. The course will review PBPK modelling and build models to predict drug release. No prior modelling experience is required — participants are simply expected to learn fast and apply the techniques immediately to their own LAI programmes. You will also learn model applications for evaluating virtual bioequivalence by applying population variability to systemic parameters (volume of distribution, clearance, etc.) — a critical capability for supporting regulatory submissions and reducing reliance on costly in vivo studies. Course Structure Duration: Accessible for 30-days post-registration, providing ample time for comprehensive learning and review. Certificate of Completion: Earn a prestigious certificate by completing the course.  Practical Assignments: Engage with hands-on assignments integrated within modules, complete with detailed instructions and tutors avaibale during office hours to suit you.  No Downloadable Materials: To prioritize active engagement, recordings and lecture slides are unavailable for download, fostering focused learning. Prerequisites: Delegates should be familiar with the Simcyp Simulator  Software: A temporary (4-day) license is provided to subscribers of this course along with x1 office hour with an expert tutor. When you are ready to start the practice exercises in this course, contact us to request your license (please allow up to 48hrs) and arrange your office hour.  Accessing the Course: After registering for this course, access your Dashboard.  You will have access to this course for a period of 30-days after the purchase.  The purchase is for a single seat in the course. No sharing the login between different individuals is allowed. Additional seats must be purchased if more than one person wishes to take the training course. Course Length: The course provides approximately 6 hours of video instruction which includes a practical component that you can do at your own pace. It is expected to take participants about 8+ hours to complete, including time to perform the tasks in the Simcyp Simulator. Overview This workshop provides a comprehensive introduction to the mechanistic modelling and simulation of long-acting injectable (LAI) formulations. Combining structured lectures with practical, hands-on exercises, participants will learn how to build, parameterise, and apply physiologically based models for polymer-based LAIs — including PLGA implants, in situ gel-forming systems and suspension formulations. The programme covers the full workflow from in-vitro release testing through to virtual bioequivalence assessment, equipping attendees to apply these approaches to their own drug development and regulatory questions — shortening development timelines and strengthening regulatory submissions. Who Should Attend Scientists and researchers in formulation development, pharmacokinetics, PBPK modelling, and regulatory science who work with — or wish to work with — long-acting injectable products, whether you're building foundational LAI modelling skills or sharpening advanced expertise. What You Will Learn Across two models — PLGA implants and LAI suspensions — comprising ten lectures (approximately 6 hours of instruction) and seven guided hands-on exercises, participants will: Understand the model theory underpinning polymer-based LAIs Address current gaps in in vitro release testing (IVRT) and apply the IVRT module Parameterize in vitro and in vivo models Apply parameter estimation and sensitivity analysis to LAI implant models Perform virtual bioequivalence (VBE) testing of PLGA-based LAIs Extend the same workflow — model theory, parameterization, and VBE — to long-acting injectable suspension formulations Lectures PLGA Implant Model Introduction to long-acting injectables workshop (25 min) A lecture on model theory for polymer based LAIs (40 min) In vitro release testing: current gaps and IVRT module (25 min) Parameterisation of in vitro and in vivo models (60 min) Application of parameter estimation and sensitivity analysis in relation to long-acting injectable implant models (40 min) Virtual bioequivalence testing of PLGA based long-acting injectables (30 min) LAI Suspension Model Introduction to long-acting injectable suspension (20 min) A lecture on model theory for suspension based LAIs (30 min) Parameterisation of the LAI suspension model (45 min) Application of parameter estimation and sensitivity analysis in relation to long acting injectable suspension models (60 min) Hands-on Exercises PLGA Implant Model Goserelin in vitro–in vivo extrapolation Prediction of in vivo clinical pharmacokinetics using a case study for an in situ gel-forming implant Sensitivity analysis and parameter estimation for the in vitro release testing module Virtual bioequivalence — testing of VBE on a hypothetical case study on solid implants LAI Suspension Model LAI suspension in vitro–in vivo extrapolation Virtual bioequivalence for LAI suspension formulations Sensitivity analysis and parameter estimation for LAI suspension formulations Why Attend This Workshop This workshop translates directly into practical, applicable skills — combining focused lectures with hands-on exercises led by Certara's own LAI modelling scientists. Attendees leave with: A working knowledge of PBPK modelling for both PLGA implants and LAI suspensions — the two dominant long-acting injectable platforms Direct, guided experience building and parameterising models using real case studies, including the Goserelin in vitro–in vivo extrapolation and hypothetical VBE scenarios A practical toolkit for virtual bioequivalence testing that can reduce reliance on costly in vivo studies Personal instruction from Certara's Modelling and Simulation scientists, with the opportunity to ask questions specific to your own development programme   Ready to strengthen your LAI modelling capabilities? Reserve your seat at this hands-on workshop and gain a practical toolkit you can apply directly to your own long-acting injectable programmes. Read more