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

(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

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