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

1. Introduction to long-acting injectables workshop (25 min)
2. A lecture on model theory for polymer based LAIs (40 min)
3. In vitro release testing: current gaps and IVRT module (25 min)
4. Parameterisation of in vitro and in vivo models (60 min)
5. Application of parameter estimation and sensitivity analysis in relation to long-acting injectable implant models (40 min)
6. Virtual bioequivalence testing of PLGA based long-acting injectables (30 min)

LAI Suspension Model

1. Introduction to long-acting injectable suspension (20 min)
2. A lecture on model theory for suspension based LAIs (30 min)
3. Parameterisation of the LAI suspension model (45 min)
4. Application of parameter estimation and sensitivity analysis in relation to long acting injectable suspension models (60 min)

Hands-on Exercises

PLGA Implant Model

1. Goserelin in vitro–in vivo extrapolation
2. Prediction of in vivo clinical pharmacokinetics using a case study for an in situ gel-forming implant
3. Sensitivity analysis and parameter estimation for the in vitro release testing module
4. Virtual bioequivalence — testing of VBE on a hypothetical case study on solid implants

LAI Suspension Model

1. LAI suspension in vitro–in vivo extrapolation
2. Virtual bioequivalence for LAI suspension formulations
3. 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.