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

Long Acting Injectables Focussed Workshop   Learn how to develop in vitro release and in vivo pharmacokinetic models using long acting injectable module of Simcyp Simulator. The course will review the PBPK modelling and building of models to predict drug release. The users are not expected to have prior knowledge but are expected to learn quickly!  You will also learn model applications for evaluating the virtual bioequivalence by applying population variability to systemic parameters (volume of distribution, clearance, etc.)  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 4 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. Instructors: Detais in agenda Time    Lectures and topics discussed  15 min  Introduction to long acting injectables and considerations to be given for modeling the polymer-based long acting injectables  25 min  A lecture on model theory for polymer based LAIs   15 min  In vitro release testing: Current gaps and experiments/formulation CQA, IVRT module         40 min  Parameterization of in vitro and in vivo models  40 min  Application of parameter estimation and sensitivity analysis in relation to long acting injectable implant models  30 min  Virtual bioequivalence testing of PLGA based long acting injectables    Hands-on workshop In vitro release testing of a solid implant (HOS1)    Hands-on workshop In vitro in vivo extrapolation to predict the clinical pharmacokinetics of Buserelin (HOS2)    Hands-on workshop Prediction of in vivo clinical pharmacokinetics using a case study for in situ gel-forming implant (HOS3)    Hands-on workshop Virtual Bioequivalence- Testing of VBE on a hypothetical case study on solid implants (HOS4)  Read more

Please note... Only email addresses from verified organisations will be accepted to participate in this course. In this workshop you will get familiar with the general concepts and application of In Vitro In Vivo Extrapolation (IVIVE) linked Physiologically Based Pharmacokinetic (PBPK) models. The fundamental concepts of separation of systems, drug and trial design parameters and incorporation of physiological and biological parameters in prediction of PK parameters and profiles are described. In addition, the applications of PBPK models for predicting transporters function and metabolism- and transporter-mediated drug-drug interactions are explained. 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.  No Downloadable Materials: To prioritize active engagement, recordings and lecture slides are unavailable for download, fostering focused learning. 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.   Please Note: This is a pre recorded course from The student boot camp held in July 2025. It contains reference to access to the Simcyp Simulator. Please note access is not provided for this On demand course.  Read more

This on-demand workshop focusses on in silico-based mechanistic prediction of dermal drug absorption. The details of the models used to mechanistically predict skin absorption after topical application will be explained. In addition examples of using mechanistic physiologically-based in vitro-in vivo correlation (IVIVCs), and virtual bioequivalence (VBE) concepts will be presented. 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 7 hours of video instruction which includes a practical component that you can do at your own pace. It is expected to take participants about 14+ hours to complete, including time to perform the tasks in the Simcyp Simulator. Instructors: Detais in agenda Lectures and topics discussed: General introduction to the course Video 1. INTRODUCTION Dermal absorption – introduction and fundamentals of the skin and model structures, diseased populations 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 Dermal absorption – mathematical principles of the MPML MechDermA model Video 4. MPML MechDermA MODEL (COMPOUND) PARAMETRIZATION Video 5. MPML MechDermA MODEL OUTPUTS Dermal absorption – how to account for variability in various populations Video 6. DERMAL TRIAL DESIGN – MULTIPLE APPLICATION SITES Video 7. PARAMETERISATION OF INTER-INDIVIDUAL VARIABILITY Dermal absorption – role of drug formulation and its metamorphosis on API absorption Video 8. IN VITRO TOPICAL FORMULATION CHARACTERIZATION 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 examples Video 13. SKIN PERMEATION IN VITRO Video 14. IVPT MODULE AND ACCOUNT FOR LLOQ IN THE SIMULATIONS Video 15. IVPT MODULE CASE STUDY Virtual BE – concepts and application examples Video 16. VIRTUAL BE FOR DERMAL FORMULATIONS – CONCEPTS Video 17. TOPICAL PRODUCT VBE CASE STUDY Hands-on work-throughs: Hands-on workshop on MPML GUI and functionality Hands-on workshop on trial design and inter-application site correlation application Hands-on workshop on role of drug formulation and its metamorphosis on API absorption Hands-on workshop on IVPT module and generic membrane model Hands-on workshop on IVPT and IVIVE Hands-on workshop on 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

Simcyp Focused Workshop: Best Practice, June 16-20, 2025 | ONLINE It is assumed that the participants are familiar with the fundamentals of PBPK modeling and have hands-on experience. The aim of this focused workshop is to demonstrate the application of best practices in developing PBPK models, and to show how to verify and refine model performance. Various case studies, including real-life examples, will be presented. The case studies will cover key elements of model development, including DDIs, specific populations, transporters, and different formulations. Optimal in vitro and clinical datasets will be discussed. Participants will learn how to select the most suitable models and evaluate the impact of relevant assumptions on model performance. Requirements for regulatory submissions will also be discussed. This is an intermediate-level workshop intended for participants with a basic understanding of PBPK modelling and some prior hands-on experience. It is assumed that the participants are familiar 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