MonolixSuite Spring School: High - Impact Pharmacometrics Case Studies Beyond routine PKPD: TMDD, Oncology, conc-QTc, Biosimilars and MBMA Free Online Training | March 23 - 27, 2026   Why This Training Matters Most pharmacometric projects don’t start out as “advanced.” They become advanced the moment a standard PK model is no longer enough. When that shift happens, the questions change: How do you choose the right TMDD approximation for a biologic? How do you model tumor response when dropout is driven by progression rather than "missing-at-random"? What makes a conc-QTc analysis workflow truly submission-ready? How do regulators expect biosimilarity to be demonstrated? Where do you start with MBMA across multiple trials? These approaches—TMDD, tumor growth dynamics, conc-QTc, biosimilars, and MBMA—shape critical development decisions. Yet, they often feel intimidating or reserved for specialists. The real challenge is rarely the equations themselves. The difficulty lies in turning a complex biological problem into a structured, interpretable, and defensible analysis. Until now, mastering these workflows has been a slow process: guidance is scattered, best practices are often learned only under project pressure, and many modelers hesitate to step into areas that seem “expert-only.” The MonolixSuiteTM Spring School is designed to make these workflows accessible through a clear, expert-guided learning path. Across five focused case studies, you will learn complete workflows — from model building and diagnostics to simulation-based decision support and standardized reporting. The Outcome? You will leave with: Practical strategies for non-standard data types and challenges. Reusable project workflows you can apply immediately. The confidence to tackle complex modeling questions far beyond routine PK/PD. How You Will Learn The MonolixSuite™ Spring School is a modular, expert-guided and interactive course, designed to help you focus on the sessions most relevant to your work while building confidence in advanced workflows. Comprehensive Onboarding & Prerequisites A full introductory Monolix course (based on previous Spring School sessions) will be available in advance, ensuring that everyone starts with a solid foundation in MonolixSuite basics. Five live online sessions led by MonolixSuite™ experts Learn directly from the people who develop and apply these workflows, gaining not only software instructions but insight into best practices, scientific reasoning, and real-world decision contexts. Two identical 1.5-hour time slots per day + video recordings Choose the session time that fits your schedule, participate live, ask questions, and revisit key concepts through recordings afterwards. Interactive Live Q&A and Safe Learning Environment Get immediate expert answers to real-time challenges. Ask the practical questions that rarely fit into tutorials: “I tried this but it didn’t work, why?”, “Is this assumption scientifically correct?”, or “How do I justify this in a report?” Guided hands-on exercises with explained solutions Reinforce each session through practical exercises, supported by dedicated solution walk-through videos, so you can replicate the workflows independently after the course. Comprehensive learning package Leave with a library of presentations, datasets, and reusable Monolix projects and Quarto scripts. Use these as templates to accelerate your own project work long after the course ends. Certificate of attendance - Demonstrate your advanced thematic training in the MIDD community. Free temporary license for all MonolixSuite™ applications - Experiment with the software during the school, apply workflows to your data, explore advanced features, and turn learning into immediate project impact. COURSE FORUM: Connect with an international community of modelers Join a global network of pharmacometricians working on the same challenges. Exchange best practices, discuss regulatory expectations, explore future directions, and build professional connections beyond the sessions. Skills and Insights You Will Gain Session 1: Target-Mediated Drug Disposition (TMDD): Navigating Complexity in Biologics TMDD is a mechanism that can fundamentally reshape a biologic’s PK, but the variety of TMDD models can be overwhelming. In this session, you will learn how to decide between full, QE/QSS, IB, or Michaelis–Menten models based on what your data actually supports. We address the primary bottleneck—parameter identifiability—and demonstrate how Simulx exploration helps to investigate which parameters can be estimated with confidence. Through expert-guided diagnosis of real mAb case studies, you will learn to ensure that parameter uncertainty remains low enough to support reliable and valuable simulations. Session 2: Tumor Growth Inhibition (TGI): Building Defensible Models from Imperfect Data TGI models are the backbone of oncology development, but the real challenge lies in building analyses that remain defensible when standard diagnostics look "wrong." In this session, we move beyond basic curve-fitting to explore critical strategic decisions, such as growth model selection. You will also learn to navigate the "dropout trap," where progression-driven missing data biases standard diagnostic plots, and master specific VPC bias correction techniques. Through a guided case study, you will leave with a simulation-ready workflow for optimizing doses and schedules, even when working with imperfect clinical data. Session 3: Concentration-QTc: Automated Workflows for Regulatory Success Building a submission-ready C-QTc assessment involves much more than fitting a single model. In this session, you will learn the standard regulatory-expected workflow for evaluating QT liability: from baseline correction and dataset preparation to model fitting and confidence interval interpretation at clinically relevant exposures. You will also discover how to automate the entire process through an R-based workflow that generates Monolix projects, key diagnostic outputs, and standardized reports. Less standard cases such as how to handle the absence of placebo data, non-linear conc-QTc relationship or hysteresis will also be covered. By the end, you will know how to deliver a complete, reproducible C-QTc assessment that meets the highest regulatory standards. Session 4: Biosimilars: Model-Informed Strategies for Similarity Testing Planning biosimilarity trials is challenging because true product differences are subtle, yet study outcomes are highly sensitive to inter-individual variability and design assumptions. This session explores how the FDA and EMA evaluate biosimilars and how simulations can be used to guide biosimilarity trial design decisions. Using a pegfilgrastim case study, you will see how sensitivity analyses identify the most informative dose levels and how clinical trial simulations guide sample size and power calculations. You will leave with practical tools and scientifically defensible modeling strategies to support biosimilar development programs. Session 5: Model-Based Meta-Analysis (MBMA): Evidence Synthesis for Decision Support MBMA allows you to benchmark a compound against competitors and predict Phase 3 performance by integrating trial-level data from literature into a single decision framework. In this session, you will learn how to model longitudinal endpoints, handle between-study and between-arm variability, and optimize parameter estimation settings. Using real-world case studies in osteoarthritis and rheumatoid arthritis, we demonstrate how MBMA supports external benchmarking by calculating the probability of trial success. This is one of the most powerful workflows for turning existing clinical evidence into strategic, forward-looking development decisions. Read more

March 23rd – 27th, 2026 (Virtual) – The PBPK Spring School introduces beginner modelers to PBBM-PBPK modeling in GastroPlus®. Over five sessions, participants learn to use PBBM-PBPK models to perform virtual bioequivalence and assess food effects. With hands-on training, expert guidance, and a temporary license, attendees gain practical skills to support biopharmaceutics and regulatory decisions.  GastroPlus® Spring School: From PBPK Basics to Biopharmaceutics Applications Introduce the essential principles for validating PBBM-PBPK models and explore their application to address biopharmaceutics-related questions.  Why This Training Matters The PBPK Spring School is designed for beginner modelers willing to learn the basics of PBBM-PBPK modeling and to go further using this concept in GastroPlus. Over five intensive sessions you'll learn how to simulate an API distribution and elimination following intravenous administration using a compartmental model, setup parameters influencing absorption, and use your validated PBBM-PBPK models to perform Virtual Bioequivalence for immediate and controlled released drug products. You will also learn how to assess Food effect using GastroPlus. More than a software tutorial, this course gives you the framework, skills and mindset to support Biopharmaceutics applications, and regulatory decisions. You'll see not only "how" to use novel GastroPlus features but "why" they must be utilized in a certain order, to support your PBBM-PBPK model endeavor. With hands-on exercises, live expert guidance, and a free temporary GastroPlus™ license, you'll be able to experiment directly on your own projects and bring back immediately usable workflows to your team. How You Will Learn • Five Live online lectures led by GPX™ experts each day Learn directly from the people who develop and use the tools at the highest level, gaining not just instructions but insight into best practices, strategies, and real-world applications. • Two identical 2 h sessions per day - choose the time zone that fits you - and video recordings Ensure you can participate live, ask questions, and learn at your best time without missing content or interaction. • Interactive Q&A chat during each session with GPX™ experts Get immediate answers to your modeling challenges and clarify concepts as you learn, turning lectures into active problem-solving sessions. • Hands-on exercises to reinforce new skills Apply what you've just learned in a guided environment, moving from theory to practice and cementing your ability to replicate these workflows later. • Comprehensive materials: presentations, datasets, and GPX projects Build your own reference library to revisit concepts, test workflows on your own time, and accelerate mastery after the course. • Certificate of attendance Demonstrate your training in advanced PBPK and GPX to colleagues, supervisors, or regulatory bodies. Free temporary license for GPX™ Use the same tools you're learning on your own projects, experiment with advanced features, and get immediate help from experts during the course - turning learning into direct project impact. Skills and Insights You'll Gain  Session 1: Getting Started with GastroPlus: Building a Solution PBPK Model In this first session, you will learn how to think like an advanced modeler developing a baseline PBPK model for an oral solution drug product. Through a step-by-step case study, you will practice selecting the appropriate disposition compartmental model to describe a drug’s pharmacokinetics following intravenous administration, then extend it to characterize oral absorption of a solution formulation. By the end, you will be able to confidently build a fully validated PBPK model; a prerequisite for PBBM-PBPK model development.  Session 2: From Solubility to Dissolution: Fundamentals for Oral Drug Absorption Modeling  GastroPlus has an intuitive interface, but behind all solubility, dissolution, and precipitation settings are mechanistic models that directly shape your predictions. In this session, you'll uncover how these processes are represented, how key parameters and assumptions influence absorption outcomes, and why understanding them is critical for building credible PBPK models describing oral absorption of oral drug products. By the end, you'll be able to confidently adjust solubility, dissolution and precipitation inputs, and generate more reliable insights for biopharmaceutics decision-making.  Session 3: PBBM-PBPK model for Immediate Release Drug Products  In this session, you will build on the validated baseline PBPK framework developed in Session 1 and the key solubility, dissolution, and precipitation concepts introduced in Session 2 to create robust PBBM-PBPK models for immediate-release drug products informed by in vitro data. By the end, you will be able to translate biopharmaceutic insights into predictive simulations, support formulation decisions through virtual bioequivalence assessments, and confidently defend your modeling strategy in regulatory discussions.  Session 4: PBBM-Based IVIVC for Controlled Release Drug Products In this session, you will extend the principles learned in earlier sessions to the development of PBBM-PBPK models for controlled-release drug products, where formulation performance plays a central role in defining clinical exposure. You will be introduced to the concept of In Vitro–In Vivo Correlation (IVIVC) and learn how to establish and validate a mechanistic IVIVC using GastroPlus. By the end, you will be able to build a PBBM-PBPK model capable of evaluating formulation changes for controlled-release drug products through virtual bioequivalence simulations and supporting regulatory strategies with mechanistic, science-based evidence.  Session 5: Assessing Food Effects on PK: A PBPK Modeling Approach To conclude this Spring School, we will shift our focus to the impact of gastrointestinal physiology on drug absorption, with particular emphasis on food effects. You will explore the key physiological changes associated with food intake, such as alterations in gastric emptying, pH, bile salts, and fluid volumes, and understand how they influence drug performance in vivo. By the end, you will be able to use a PBPK model to anticipate food-related risks and support the design of formulations that minimize or avoid clinically significant food effects.  Read more

April 14th, 2026 (In Person) - This course is designed for beginners who want to learn the fundamentals of population pharmacokinetic (PK) modeling and simulation with MonolixSuite. It provides a practical introduction to building, evaluating, and using PK models to support data analysis and decision-making. What you’ll learn: * How to prepare, visualize, and explore PK data * How to build and compare classical population PK models * How to evaluate model performance using typical diagnostic tools * How to perform PK simulations to explore new dosing regimens The course combines lectures with hands-on exercises using MonolixSuite™. A temporary software license is included. Read more

June 1-2, 2026 (In Person) -  This is a bundle registration that includes both the Monolix Workflow Lab and AI Lab course. Monolix Workflow Lab: Reproducibility and traceability are well known requirements — yet many modeling workflows remain manual and difficult to review. This Workflow Lab shows how to move from one-off analyses to standardized, automated pipelines using MonolixSuite and R-based tools. Through hands-on examples, you’ll learn how to build workflows that support efficient reruns, consistent outputs, and review-ready reporting. Beginner MonolixSuite online training is included. AI Lab: A small shift in how AI is used makes a big difference between generic answers and scientific support. This hands-on AI Lab introduces MonolixSuite’s specialized AI assistants through guided examples designed for reproducibility, traceability, and regulatory-ready workflows. You’ll explore where AI can meaningfully support pharmacometric modeling today — and where human expertise remains essential. No prior MonolixSuite or LLM experience is required. MonolixSuiteTM Workflow Lab: From Automated Analysis to Submission-Ready Deliverables MonolixSuiteTM AI Lab: From Concepts to Agents - Practical AI Use Cases for Modelers PAGE 2026 Satellite Workshops Workflow Lab: Full day: Monday afternoon 1st June 2026: 1 – 5 PM and Tuesday morning 2nd June 2026: 9 AM – 12 PM AI Lab: Half day: Tuesday afternoon, 2nd June 2026: 1  – 5 PM Workflow Lab Description The transition from manual, one-off analyses to standardized, automated pipelines is changing how modellers handle frequent data updates, reruns, tight timelines, and review expectations. This workflow Lab helps to make that transition by building end-to-end workflows that are reproducible, traceable, and ready for efficient internal and regulatory review. Through technical lectures and guided hands-on exercises, you will learn to automate data formatting and plots customization via presets, run Monolix automatically with lixoftConnectors, standardize outputs, and generate reports with Quarto. The course also covers practical quality and submission-oriented practices, including software installation documentation/validation, version control, and generating standardized output and plot packages for submissions. By the end of the workshop, you will have a structured workflow example that supports reproducibility, traceability, and submission preparation and can be adapted to your own projects. New to MonolixSuite? No problem. To support participants with different backgrounds, registration includes free access to our online beginner training. These self-paced resources help you get the most out of the course. Includes a temporary licence for the MonolixSuite. This is an IN-PERSON WORKSHOP taking place in Dubrovnik, Coratia, as a satellite event of the PAGE conference. AI Lab Description Large Language Models (LLM) are widely discussed across the industry, but their practical and safe application within a regulated scientific environment remains little understood. In pharmacometrics, there is a gap between a generic AI response and outputs that are reproducible, reviewable and appropriate for scientific decision making. This AI Lab addresses that gap with a practical, hands-on introduction to MonolixSuite specialized AI assistants.  Working with early access beta tools in MonolixSuite, you will use guided examples to explore how AI can support tasks such as drafting model elements, generating code, and supporting workflows. The session includes an introduction to the Model Context Protocol (MCP) to connect AI assistants with a modeling environment. By including realistic applications and acknowledging current limitations, the AI Lab will help you develop a clear view on what AI can support today, and how to use these tools safely and effectively in your own workflows.  New to MonolixSuite? No problem. To support participants with different backgrounds, registration includes free access to our online beginner training. These self-paced resources help you get the most out of the course. Includes a temporary licence for the MonolixSuite. This is an IN-PERSON WORKSHOP taking place in Dubrovnik, Coratia, as a satellite event of the PAGE conference. More courses at PAGE "MonolixSuite Modeling Lab: Practical Solutions for Advanced PKPD Challenges" . Price per person The prices are VAT exempted, it will be added if applicable. Industry: 939$ (~800€) – Academia: 470$ (~400€)   Lunch on Tuesday is included.   Payment Method: Credit Card*  *If you are unable to complete payment with a credit card please contact education@simulations-plus.com to request and invoice to pay via direct wire transfer. Location This is an in-person workshop in Dubrovnik in Croatia.  Read more

June 1-2, 2026 (In Person) -  This is a bundle registration that includes both the MonolixSuite Modeling Lab and AI Lab courses. Modeling Lab: MonolixSuite provides powerful estimation and diagnostic tools — yet their correct interpretation is often the hardest part of model development. This Modeling Lab focuses on practical problem solving to help you understand algorithm behavior, diagnostics, and the reasoning behind modeling decisions. Through guided hands-on examples and real troubleshooting cases, you’ll learn how to approach complex models with confidence and structure. Beginner training is included. AI Lab: A small shift in how AI is used makes a big difference between generic answers and scientific support. This hands-on AI Lab introduces MonolixSuite’s specialized AI assistants through guided examples designed for reproducibility, traceability, and regulatory-ready workflows. You’ll explore where AI can meaningfully support pharmacometric modeling today — and where human expertise remains essential. No prior MonolixSuite or LLM experience is required. MonolixSuiteTM Modeling Lab: Practical Solutions for Advanced PKPD Challenges MonolixSuiteTM AI Lab: From Concepts to Agents - Practical AI Use Cases for Modelers PAGE 2026 Satellite Workshops Modeling Lab: Full day: Monday afternoon 1st June 2026: 1 – 5 PM and Tuesday morning 2nd June 2026: 9 AM – 12 PM AI Lab: Half day: Tuesday afternoon, 2nd June 2026: 1  – 5 PM Modeling Lab Description Complex model development requires more than following a standard workflow; it requires understanding and interpretation of estimation algorithms and diagnostics. This modeling Lab moves beyond reviewing software features and focuses on practical problem solving to help you make good modeling decisions.  During technical lectures and guided hands-on sessions, you will explore diagnostic tools using different settings, gain practical insight into estimation algorithms behaviour, and work through examples of complex model building. Part of the session includes interactive troubleshooting based on real issues encountered in Monolix support, illustrating how to approach problems from both a modeling and technical perspective. To make the experience as relevant as possible, participants are invited to pre-submit specific questions, datasets or models (details provided after registration), with selected cases discussed live during the workshop.  New to MonolixSuite? No problem. To support participants with different backgrounds, registration includes free access to our online beginner training. These self-paced resources help you get the most out of the live, instructor-led coaching. Includes a temporary licence for the MonolixSuite. This is an IN-PERSON WORKSHOP taking place in Dubrovnik, Coratia, as a satellite event of the PAGE conference. AI Lab Description Large Language Models (LLM) are widely discussed across the industry, but their practical and safe application within a regulated scientific environment remains little understood. In pharmacometrics, there is a gap between a generic AI response and outputs that are reproducible, reviewable and appropriate for scientific decision making. This AI Lab addresses that gap with a practical, hands-on introduction to MonolixSuite specialized AI assistants.  Working with early access beta tools in MonolixSuite, you will use guided examples to explore how AI can support tasks such as drafting model elements, generating code, and supporting workflows. The session includes an introduction to the Model Context Protocol (MCP) to connect AI assistants with a modeling environment. By including realistic applications and acknowledging current limitations, the AI Lab will help you develop a clear view on what AI can support today, and how to use these tools safely and effectively in your own workflows.  New to MonolixSuite? No problem. To support participants with different backgrounds, registration includes free access to our online beginner training. These self-paced resources help you get the most out of the course. Includes a temporary licence for the MonolixSuite. This is an IN-PERSON WORKSHOP taking place in Dubrovnik, Coratia, as a satellite event of the PAGE conference. More courses at PAGE "MonolixSuite Workflow Lab: From Automated Analysis to Submission-Ready Deliverables" . Price per person The prices are VAT exempted, it will be added if applicable. Industry: $939 (~800€) – Academia: $470 (~400€)   Lunch on Tuesday is included.   Payment Method: Credit Card*  *If you are unable to complete payment with a credit card please contact education@simulations-plus.com to request and invoice to pay via direct wire transfer. Location This is an in-person workshop in Dubrovnik in Croatia.  Read more

June 2, 2026 (In Person) -  MONOLIXSUITE PAGE 2026 SATELLITE WORKSHOPS This hands-on AI Lab introduces MonolixSuite’s specialized AI assistants through guided examples designed for reproducibility, traceability, and regulatory-ready workflows. You’ll explore where AI can meaningfully support pharmacometric modeling today — and where human expertise remains essential. No prior MonolixSuite or LLM experience is required. MonolixSuiteTM AI Lab: From Concepts to Agents - Practical AI Use Cases for Modelers PAGE 2026 Satellite Workshop Half day: Tuesday afternoon June 2nd: 1  – 5 PM Course description Large Language Models (LLM) are widely discussed across the industry, but their practical and safe application within a regulated scientific environment remains little understood. In pharmacometrics, there is a gap between a generic AI response and outputs that are reproducible, reviewable and appropriate for scientific decision making. This AI Lab addresses that gap with a practical, hands-on introduction to MonolixSuite specialized AI assistants.  Working with early access beta tools in MonolixSuite, you will use guided examples to explore how AI can support tasks such as drafting model elements, generating code, and supporting workflows. The session includes an introduction to the Model Context Protocol (MCP) to connect AI assistants with a modeling environment. By including realistic applications and acknowledging current limitations, the AI Lab will help you develop a clear view on what AI can support today, and how to use these tools safely and effectively in your own workflows.  New to MonolixSuite? No problem. To support participants with different backgrounds, registration includes free access to our online beginner training. These self-paced resources help you get the most out of the course. Includes a temporary licence for the MonolixSuite. This is an IN-PERSON WORKSHOP taking place in Dubrovnik, Coratia, as a satellite event of the PAGE conference. More courses at PAGE This course is for FREE if combined with a full day course (Monday afternoon + Tuesday morning): MonolixSuite Modeling Lab or MonolixSuite Workflow Lab   Price per person The prices are VAT exempted, it will be added if applicable. Industry: $470 (~400€) – Academia: $235 (~200€)   If you want to join also a full day workshop, please register via these links: AI Lab + Modeling Lab AI Lab + Workflow Lab  Lunch on Tuesday is included.   Payment Method: Credit Card*  *If you are unable to complete payment with a credit card please contact education@simulations-plus.com to request and invoice to pay via direct wire transfer. Location This is an in-person workshop in Dubrovnik in Croatia.  Read more