Calvagone
On June 3rd Calvagone will be running a 1-day workshop on e-Campsis, an intuitive web application to set-up and run PK/PD & QSP simulations, and to communicate simulation results in an interactive way.
As a participant you will get free access to e-Campsis pro. You will learn how to:
- Import a model from various sources (Campsis, model library, NONMEM)
- Set up a trial design
- Bootstrap covariates from an external source (e.g. NHANES)
- Explore what-if scenarios thanks to the built-in scenario creator
- Stratify and visualize the results with customizable plots
- Post-process the results, derive useful metrics and summary statistics and generate HTML tables in a few clicks
- Overlay external data on top of simulations
- Create forest plots in an intuitive manner to assess the impact of covariates
- Make a sensitivity analysis effortlessly and understand the limitations of your model
You will also learn how to reproduce the simulations offline in R thanks to the open-source package campsis.
The following registration fee applies for this 1-day workshop:
Industry: € 200 (100*) excl. VAT
Academic: € 100 (50*) excl. VAT
Student: € 100 (50*) excl. VAT
*Register and pay before April 1st to get a 50% early bird discount!
The fee includes the workshop material, lunch and coffee breaks as well as temporary access to e-Campsis pro for 3 months.
Only limited knowledge of R is required, since all hands-on exercises will be done in the web application. Participants should bring their own laptop.
The course will take place at Hotel Capsis 4* https://capsishotels.gr/en - 400 m from the metro station of Dimokratias.
Please click on the link below to register.
https://forms.office.com/e/tUjcgxChzM
PS: If you already want to familiarize yourself with e-Campsis before the workshop, feel free to explore the free version at https://www.e-campsis.com.
Certara
Workshop: Machine Learning Model Selection in NLME/NONMEM with Pirana and R
Location: PAGE 2025 Conference Venue, close to Thessaloniki Concert Hall (exact meeting space to be announced)
Date and time: Tuesday, 3 June 2025 from 09:00 to 17:00
This full day workshop will introduce the student to machine learning PMX analyses in R using Certara’s R speaks NLME, Pirana, R-Darwin-NLME and Pirana-Darwin-NONMEM. By the end of the course, students will be able to create a pk model in R using the PML language, fit the model, perform diagnostics including VPC, and perform simulations. In addition, students will be given an introduction to executing a machine learning model selection analysis using Pirana Darwin.
The workshop will include lectures and hands-on exercises. Participants will be given temporary licenses to the software being used in this course to perform the hands-on exercises. Each participant must bring their own laptop and be familiar with the fundamental use of R software.
Instructors:
Keith Nieforth, PharmD
Mark Sale, MD
$200 for Industry and $100 for academia (lunch included)
Read the full details and register here
Educational Pharmacometrics Summer Symposium
The fourth Educational Pharmacometrics Summer Symposium (EPSS) will take place on 3 June 2025, close to the PAGE venue (here). This free one-day symposium will bring together experts and professionals in the field of pharmacometrics (PMx) to give an overview of what pharmacometrics is and how it can contribute to model-informed drug development and therapy individualisation. The symposium is an excellent opportunity to gain valuable knowledge about PMx, PMx-related career possibilities, establish professional relationships, and present your work.
The symposium will begin with a brief introduction to PMx, followed by a discussion on the use of PMx in drug development, covering preclinical and clinical applications. After lunch and networking, the use of PMx to optimise and personalise treatment, will be presented, followed by PMx case studies, which will be based on submitted student abstracts. The symposium will conclude with a short group work session (programme).
The symposium is intended for MSc/PhD students from all natural sciences, postdocs, and others with an interest in pharmacometrics, such as, clinical pharmacists, clinicians, mathematicians, statisticians, or colleagues from industry.
Students/postdocs may apply to present their original PMx-related work as a part of the symposium (submitted abstract should not exceed 4,500 characters, including spaces, and may be the same as for the PAGE 2025 meeting); abstract submission deadline is 4 May 2025.
The participation is free of charge. Light lunch will be provided. Based on last years’ positive feedback, register early to avoid missing out: link (open until 4 May 2025). For more information, please email 4thEPSS2025@gmail.com.
This event is supported by Boehringer Ingelheim, Pharmetheus and National and Kapodistrian University of Athens.
ESQLabs
Workshop Day 1: PBPK Modeling in OSP Suite V12 – Foundations and Special Populations
Date: Monday, 2nd June, 2025
Time: 09:00 - 17:00
Location: Daios Luxury Living Hotel -Thessaloniki | Greece
Instructors: Dr Stephan Schaller and Dr Raphaelle Lesage.
Physiologically-based pharmacokinetic (PBPK) modeling is a relevant approach to streamline drug development, providing a mechanistic framework to predict drug behavior across different populations. With the latest developments in OSP Suite V12, PBPK modeling has become even more intuitive, efficient, and scalable. This hands-on workshop will guide participants through the basis of PBPK modeling using PK-Sim, with a special focus on paediatric, geriatric, and organ-impairment applications.
Fees:
- Commercial/Industry: 500 (400*) EUR excl. VAT
- Academia/Government: 300 (250*) EUR excl. VAT
- Students: 150 (100*) EUR excl. VAT
*Early bird pricing valid until April 7th
Click below to learn more details on the agenda and Register Now
Workshop Day 1 (PAGE 2025) – ESQlabs GmbH
Workshop Day 2: Building Scalable PBPK-QSP Models – Modularization in MoBi for OSP Suite V12
Date: Tuesday, 3rd June, 2025
Time: 09:00 - 17:00
Location: Daios Luxury Living Hotel -Thessaloniki | Greece
Instructors: Dr Stephan Schaller, Dr Wilbert de Witte and Pavel Balazki.
The latest OSP Suite V12 introduces a revolutionary modularization approach that significantly enhances the flexibility, scalability, and efficiency of quantitative systems pharmacology (QSP) modeling and integrations with physiologically-based PK (PBPK-QSP). This full-day hands-on workshop will equip participants with the skills to leverage modular workflows in MoBi to build, extend, and refine PBPK-QSP models like never before. Led by ESQlabs scientists, attendees will start with a simple two-compartment model to grasp the fundamentals of modularization before diving into a real-world case study: modeling an ADC modality for tumor treatment.
Fees:
- Commercial/Industry: 500 (400*) EUR excl. VAT
- Academia/Government: 300 (250*) EUR excl. VAT
- Students: 150 (100*) EUR excl. VAT
*Early bird pricing valid until April 7th
Click below to learn more details on the agenda and Register Now
Workshop Day 2 (PAGE 2025) – ESQlabs GmbH
Workshop Day 3: Modular PBPK Modeling and Quality-Controlled Simulation Workflows in R with OSP Suite V12 – Use Case: Pregnancy PBPK
Date: Saturday, 7th June, 2025
Time: 09:00 - 17:00
Location: Daios Luxury Living Hotel -Thessaloniki | Greece
Instructors: Pavel Balazki and Nina Nauwelaerts.
This full-day workshop offers a powerful combination of hands-on modular customized PBPK(-QSP) modeling and quality-controlled simulation workflows in R, leveraging the latest advancements in OSP Suite V12. Participants will explore the new modularization framework in PK-Sim and MoBi, learning how to extend a PBPK model with a pregnancy module to simulate fetal drug exposure. The second half of the workshop focuses on streamlining PBPK-QSP modeling workflows in R using {esqlabsR}, a package designed to enhance reproducibility, transparency, and automation.
Fees:
- Commercial/Industry: 500 (400*) EUR excl. VAT
- Academia/Government: 300 (250*) EUR excl. VAT
- Students: 150 (100*) EUR excl. VAT
*Early bird pricing valid until April 7th
Click below to learn more details on the agenda and Register Now
Workshop Day 3 (PAGE 2025) – ESQlabs GmbH
ICON
Advanced Features of NONMEM 7 Workshop for PAGE 2025
Date: Monday, 2nd June, 2025
Time: 09:00 - 17:00
Location: Thessaloniki | Greece
Timezone: (GMT +1:00) Central European Time
A one-day in person NONMEM 7 course will be presented by ICON at the PAGE 2025 Conference
A one-day NONMEM 7.6 course will be presented by ICON at the PAGE 2024 Conference. This one-day, in-person, workshop will cover the description and use of features in NONMEM 7. Workshop attendees will be instructed how to specify gradient precision and how to use the FAST algorithm (new in NM 7.4) for FOCE and will also be instructed on how to use the Monte Carlo importance sampling, stochastic approximation expectation-maximization methods, and full Bayesian methods such as Gibbs sampling and Hamiltonian no-U turn sampling (new in NM 7.4). Parallel computing and dynamic memory allocation for efficient memory usage will also be described as well as symbolic references to thetas, etas, and sigmas, priors to sigmas, MonteCarlo search algorithms to improve FOCE estimation, built-in individual weighted residuals, bootstrap tools for simulation, and automatic stabilization against numerical exceptions. Also, learn to use new abbreviated code features for easier modeling of inter-occasion variability, modelling additional mixed effects levels for grouping individuals, such as inter-clinical site variability, and using the DO loop feature in abbreviated code, useful for handling multiple bolus doses in models that use the analytical absorption function for multiple transit compartments. New in NONMEM 7.5: Optimal clinical design and evaluation tool is available, as well as delay differential equation solvers.
Presenters: Robert Bauer, PhD,Brian Sadler, PhD, and Mohamed Ismail, PharmD/MS.
For additional information and agenda, please go to Workshop: Advanced NONMEM 7.6 (iconplc.com)
Fees: $600 for Industry, $300 for Academia/Government, $150 for Students
For more information and registration, contact Andreea Ancuta at IDSSOFTWARE@iconplc.com
InSilicoTrials
Hands-On Introduction to Clinical Trial Simulation
Date: Tuesday, 3 June, 2025
Time: 9:00 - 16:30
Location: MONASTY Hotel, 45 Vasileos Irakleiou Street, Thessaloniki, 546 23 Greece
Join us for a hands-on workshop exploring InSilicoTrials, a platform for clinical trial simulations and model-informed drug development.
Explore an in-depth, hands-on workshop where you will discover the potential of InSilicoTrials, a platform designed to simplify and enhance clinical trial simulations. Led by our expert team – VP of R&D Daniel Röshammar, Scientific Director Jane Knöchel, and Head of Engineering Matteo Gazzin – this workshop is tailored for professionals and students interested in model-informed drug development.
Whether you’re a pharmacometrician, statistician, data scientist, or pre-clinical modeler, you’ll gain practical insights into how the InSilicoTrials platform can improve collaboration, streamline simulations, and accelerate decision-making in clinical trials. The platform supports seamless integration of various prominent modeling languages, including NONMEM, Python, Matlab (featuring SimBiology), and R (with packages such as rxode2, mrgsolve, and many others). It allows you to work with complex pharmacokinetic/pharmacodynamic (PK/PD) models, quantitative systems pharmacology (QSP), and even AI/machine learning models.
Fees: Industry 150,00€ before 15th April, 300,00€ after | Students 50,00€ before 15th April, 100,00€ after
For more information and to register, visit our workshop page or email us at workshop@insilicotrials.com
LAP&P
LAP&P course; An interactive pharmacometric case study for an antibody exhibiting TMDD
In this 1.5-day course we will specifically discuss the importance of understanding the pharmacology of monoclonal antibodies (mAbs) to make the right decisions in target-mediated drug disposition (TMDD) model development. If you want to learn more on 1) the relevance of mechanistic modelling for mAbs, 2) the considerations with regards to scaling the model for first in human (FIH) approaches, and 3) what TMDD models are, what approximations may be applicable and how to use these models for (non-) clinical data.
In this LAP&P interactive course, we will mimic a real-life example of a mAb with straightforward target engagement. After a short introduction, we will directly dive into a hands-on session, in which the participants work in small groups on TMDD modelling challenges using a nlmixr2 within a shinyMixR workflow.
Workshop tutors: Tamara van Steeg & Sven Hoefman
Date & Time:
Monday 2nd of June, 13:00 -17:00
Tuesday 3rd of June, 9:00 -17:00
Venue:
Thessaloniki, Hotel Capsis
Fees:
- Commercial/Industry: 800 (600**) EUR excl. VAT.
- Academia/PHD Students: 400 (300**) EUR excl. VAT.
**Early bird until 1st of April.
Click for more information and to register
M&S DECISIONS
Model-informed approach for safe starting dose estimation in First-in-Human trials
Date and time: Monday, 2 June 2025, 09:00-17:00, lunch 13:00-14:00 (7 hours)
Target audience:
Pharmacometricians, modeling scientists and students who seek to gain in-depth knowledge of bispecific antibody drug development, with emphasis on pharmacokinetics, pharmacodynamics and practical skills in quantitative systems pharmacology modeling
Annotation:
Join us for a one-day workshop hosted by M&S Decisions, to focus on translational mechanistic modeling in support of First-in-Human (FiH) safe starting dose selection.
The topic addressed in the workshop is of utmost importance, given the intricacies in pharmacokinetics and pharmacodynamics, and the corresponding unique safety challenges inherent to this multi-component therapeutic modality. The mechanistic modeling approach presented, which we will examine in a practical, hands-on manner, represents a must-have element in CTA/IND submissions.
The case examples which we will be focusing on during the workshop are based on the actual modeling applications in the development of T cell engagers (TCE) and other types of bispecific antibodies, although the overall methodology becomes generally for other types of novel multi-component therapeutics, such as autologous and allogenic cell therapies, antibody-drug and -oligo conjugates, targeted lipid or polymer nanoparticles with encapsulated drug, PROTACs etc.
In fact, our session will take participants through various modeling approaches, from a more empirically driven workflow to estimate FiH starting dose using MABEL criteria, to a mechanistically oriented translational approach using a quantitative systems pharmacology (QSP) modeling workflow The latter will be based on an integrative cloud infrastructure, "Simurg", and a set of packages from the R programming environment.
What you will learn
The workshop covers the following key elements of FiH dose selection for bispecific antibodies:
- Therapeutic utility and challenges in the development of complex, multi-component biologics and cellular therapies;
- Implementation of FiH dose selection based on minimal anticipated biological effect level (MABEL) criteria;
- Model-based analysis of in vitro cytotoxicity data, while accommodating for diverse experimental conditions (incubation time, E:T ratio, various cell lines, etc.) using fitting algorithms implemented in NONMEM, Monolix, nlmixr and Simurg;
- Development of a translational QSP model to predict exposure-efficacy and exposure-safety relationships in patients - from exploratory data analysis to advanced diagnostics;
- Generation of virtual patient populations which take into account variabilities in PK and in diverse disease states and immunological conditions;
- Implementation of model-informed selection of pharmacologically active and safe starting doses for bispecific antibodies, based on a case study with T cell engagers (TCE);
- Regulatory requirements for inclusion of the MIDD approaches to support CTA/IND applications.
Mentors:
Victoria Kulesh, Dr. Victor Sokolov, Dr. Alina Volkova, Dr. Yuri Kosinky, Dr. Kirill Peskov
Pricing (excl. VAT):
- Industry: €500 (€250 online)
- Academics: €250 (€100 online)
- Students: €150 (free online)
25 offline seats + 25 online seats
Technical requirements:
Laptop and functional browser.
Click here to register for our workshop.
For detailed program please visit https://msdecisions.tech/category/workshop/
PD-value
Hands-on workshop on the use of IMPRES-M® in PK and population PK modeling
Would you like to learn how to use the brand-new IMPRES-M methodology to estimate PK models “without the model”? Come join us for this 1.5-day workshop where you will learn about the theory behind the impulse-response framework, and where you will get hands-on experience on how to use it.
Date and time
Monday 2nd of June, 9:00-17:00
Tuesday 3rd of June, 9:00-12:00
Venue
Megaron, Thessaloniki Concert Hall (Main venue) – Room CR-3
Instructors
Workshop host: Jeroen Elassaiss-Schaap
Workshop tutors: Vincenzo Di Iorio, Lorenzo Cifelli, Csaba Katai and Jie Ju
Workshop description
Population PK modeling is a major interest within the PAGE community. With IMPRES-M, we have proudly established a new approach to describe pharmacokinetic (PK) and pharmacodynamic (PD) curves by smoothing rather than modeling based on compartmental- or differential-equations. This is achieved in a framework that allows for simulation and extrapolation much the same way as modelers in the field are used to. You therefore can be more time-efficient in your modeling workflows by circumventing the laborious model-building step!
In this workshop you will be presented with the theory behind IMPRES-M, and you will also get some hands-on experience fitting to data with IMPRES-M, either your own datasets or one provided by us. We will start off with general smoothing , followed by its application to single-subject PK curves, population modeling, and eventually PK-PD. Furthermore, we will present extensions that are under development so you will also get to know where we will be heading next!
Learning objectives:
- Smoothing with P-splines: theory and practice (useful tool, widely applicable)
- IMPRES-M theory for PK modeling
- Hands-on single-subject PK modeling with IMPRES-M
- Non-traditional population estimation (mixed effects) approaches
- Hands-on population PK modeling with IMPRES-M
- Hands-on PK-PD modeling with IMPRES-M
- Ongoing research on IMPRES-M extensions
Target Audience
The target audience are PK or PK-PD modelers at beginner to advanced levels, who would like to extend their modeling toolkit.
Prerequisites
Attendees need to bring their own laptop with a recent version of R and Rstudio installed. Instructions to install IMPRES-M as an R package will be provided beforehand.
Registration Details
Click here to register for our workshop.
Fees for attendance are:
Student: 50€
Academy: 100€
Industry: 200€
Additional Information
Attendees will receive a license for IMPRES-M for a 4-month period.
Hands-on workshop on use of IMPRES-M® in single subject PK modeling
Would you like to learn how to use the brand-new IMPRES-M methodology to estimate PK models “without the model”? Come join us for this half-day workshop where you will learn about the theory behind the impulse-response framework, and where you will get hands-on experience on how to use it.
Date and time
Tuesday 3rd of June, 13:00-17:00
Venue
Megaron, Thessaloniki Concert Hall (Main venue) – Room CR-3
Instructors
Workshop host: Jeroen Elassaiss-Schaap
Workshop tutors: Vincenzo d’Iorio, and Lorenzo Cifelli
Workshop description
Population PK modeling is a major interest among the PAGE community. With IMPRES-M, we have proudly established a new approach to describing pharmacokinetic (PK) and pharmacodynamic (PD) curves by smoothing rather than modeling, such as compartmental or differential-equation based modeling. This is achieved in a framework that allows simulation and extrapolation, similar to what is available in compartmental models. You therefore can be more efficient in your modeling workflows!
In this workshop you will be presented by the background and theory, but you will also get your hands on fitting data with IMPRES-M, either your own or datasets provided by us. We focus on its application to single-subject PK curves. Furthermore we will present briefly about further capabilities, and extensions that are under development so you will also get to know where we will be heading next!
Learning objectives:
- IMPRES-M theory for PK modeling
- Hands-on single-subject PK modeling with IMPRES-M
- Further IMPRES-M capabilities
- Ongoing research on IMPRES-M extensions
Target Audience
The target audience are PK or PK-PD modelers at beginner to advanced levels, who would like to extend their modeling toolkit.
Prerequisites
Attendees need to bring their own laptop with a recent version of R and Rstudio installed. Instructions to install IMPRES-M as an R package will be provided beforehand.
Registration Details
Click here to register for our workshop.
Fees for attendance are:
Student: 25€
Academy: 50€
Industry: 100€
Additional Information
Attendees will receive a license for IMPRES-M for a 4-month period.
Simcyp Workshop - Designer Workshop
Tutors: Abdallah Derbalah abdallah.derbalah@certara.com & Tariq Abdulla tariq.abdulla@certara.com
Date: 3rd June 2025
Time: 08:30 – 16:30
AudioVisual Equipment: Projector, Screen, white board, power to each table (rounds)
Number of participants: Minimum 6 / Maximum 20
Food and Beverage needs: Mid morning Break / light lunch / Afternoon break
Course Title: A Hands-On Workshop with Simcyp Designer for Tailored PBPK-PD/QSP Models
Would you like to modify and tailor population PBPK models? This course will review the principles of PBPK modelling, using the Simcyp Simulator and how to use Simcyp Designer to modify existing PBPK models with your own extension and link them to custom-built PD/QSP models. We will have lectures to introduce the PBPK models to be changed and have hands-on exercises to train the customisation of PBPK models with the Designer. No prior knowledge is required. Access to the Simcyp Simulator and Simcyp Designer will be provided. Participant are required to bring their own laptops as the workshop is hands-on intensive.
Key aspects of the course:
- Overview of PBPK modelling, using the Simcyp Simulator.
- Rapidly create new models in a graphical editor – Introduction to Simcyp Designer.
- Replace PBPK model components in Simcyp with a user-defined model.
- Adding components/modules to Simcyp PBPK models.
- Extending PBPK models for large molecules.
- Building PBPK driven PD/QSP models.
- Incorporate population variability into the customized models.
- Combined model parameter estimation and sensitivity analysis
COST £250+VAT Students (Coupon Code: STUDENT25) / £500+VAT Industry
Register Here
Pharmetheus
Pharmetheus workshop: Learn and apply TTE and RTTE modeling with a focus on NONMEM
This one and a half day workshop provides a good understanding of time to event (TTE) and repeated TTE (RTTE) modeling in NONMEM, in theory and practice, by listening to and discussing with leaders from both industry and academia. Learn from key speakers including France Mentré, Lena Friberg, and Nastya Kassir.
Target audiences are students and pharmacometricians with no, or limited, previous experience of TTE/RTTE modeling. After the workshop the attendees will be able to understand, conduct and communicate TTE and RTTE modeling analyses.
Agenda highlights:
- Overview of simulation frameworks, data formatting, graphical exploration, key NONMEM coding techniques and hands-on sessions to appreciate the specificities of TTE/RTTE models in terms of evaluation and diagnostics.
- Advanced insights to NONMEM code; standard and alternative function parameterization, implementation of exposure-response relationships, and estimation of covariate effects.
- Motivation for running survival analysis from a model-informed drug development perspective,
Key speakers: France Mentré, Lena Friberg, Nastya Kassir (free for attendees of previous sessions).
Workshop host: Niclas Jonsson
Workshop tutors:, Jurgen Langenhorst, Félicien Le Louedec, Qing Xi Ooi, and Joakim Nyberg
Secure your spot now — early bird discounts available!
Date:
Monday 2nd of June, 13.00-17.00
Tuesday 3rd of June, 8.00-17.00
Venue:
Thessaloniki, Makdonia Palace Hotel
Fees:
- Commercial/Industry: 950 (750**) EUR excl. VAT.
- Academia/government/non for profit: 500 (400**) EUR excl. VAT.
- Students: 250 (200**) EUR excl. VAT.
**Early bird until 1 April.
For more information and registration visit Pharmetheus.com – Workshop: Learn & apply TTE/RTTE modeling"
Pharmetheus workshop: PBPK Modeling for First-in-Human & DDI with OSP Suite version 12
Do you want to increase your capabilities to support decision making in drug development with PBPK? This two days workshop will teach how to use and leverage the Open Systems Pharmacology (OSP) suite (also known as PK-Sim® and MoBi®) for translational modeling to inform First-in-Human and Drug-Drug interactions (DDI) in the context of ICH M12 and the recent ICH M15.
We will utilize the standardized and well-established whole body PBPK model provided in PK-Sim® and the open modeling possibilities in MoBi®.
The workshop covers aspects such as:
- The fundamentals in PK-Sim and MoBi, version 12
- How to set up a PBPK model in PK-Sim in different species (e.g., Rat, Dog and Monkey)
- How to establish an in-vitro in-vivo relationship using PBPK models
- How to retrieve reference compound files (victims and perpetrators) and enzyme/transporters framework
- How to handle non standard DDI cases, e.g. with including multiple enzymes, transporters or endogenous DDI biomarkers with MoBi
- How to verify, qualify and assess applicability of the models
- How to run simulations to inform First-in Human and DDI study designs
- How to assess model risk and give recommendations towards DDI risk for labelling
Workshop tutors: Tobias Kanacher, Johanna Eriksson, Marylore Chenel
Date:
Monday 2nd of June, 9.00-17.00
Tuesday 3rd of June, 9.00-17.00
Venue:
Thessaloniki, Makedonia Palace Hotel
Fees:
- Commercial/Industry: 1200 (900**) EUR excl. VAT.
- Academia/government/non for profit: 600 (450**) EUR excl. VAT.
- Students: 300 (250**) EUR excl. VAT.
**Early bird until 7 April.
Register now to expand your PBPK expertise - early bird discounts available!
Pharmetheus satellite symposium: Model-Informed Drug Development in Regulatory Interactions- Practical takes on the draft ICH M15 Guideline
We are happy to invite the PAGE audience to an afternoon symposium about the application of Model-Informed Drug Development (MIDD) in regulatory interactions. With the draft ICH M15 guideline on “General principles for model-informed drug development” recently posted for public consultation, there is an unprecedented opportunity for our community to bring MIDD to the next level. The aim of this symposium is to reflect on the current use of MIDD in regulatory interactions and propose practical ideas on how to put the ICH guideline into action. We encourage everyone interested in the application of MIDD to support regulatory interrelations to join, and look forward to your contribution to the discussion on this topic.
The symposium will cover:
- Introduction to MIDD and its regulatory landscape
- Overview of the ICH M15 guidance – facts and interpretations
- Expanded views on MIDD evidence
- Absence of evidence vs. evidence of absence
- Supportive evidence vs. primary evidence
- Risk-based credibility assessment
- Practical use of ICH M15 ‘Table for Assessment of MIDD Evidence’
- Model evaluation in line with the ICH M15 guideline
- Verification, validation, and applicability assessment
- Question of interest focused model diagnostics
- Planning and preparing MIDD for successful regulatory interactions
- Working with interdisciplinary teams
- Efficient processes and proactive work
- Examples of MIDD applications with regulatory impact
Speakers: Martin Bergstrand, Marylore Chenel, Emma Hansson.
Additional speakers to be announced soon!
Date: Tuesday 3rd of June
Time: 14:00 – 18:00
Venue: Thessaloniki, Makedonia Palace hotel
Fee: 185 (135**) EUR excl. VAT.
**Early bird until 1 April.
For more information and registration visit Pharmetheus.com- Symposium: MIDD in regulatory interactions
Pumas
Workshop 1 : Scientific Modeling Augmented by Machine Learning with DeepPumas
DeepPumas is a powerful tool that bridges the gap between mechanistic, statistical, and machine learning modeling. This hands-on workshop will introduce participants to the core concepts behind DeepPumas and its potential to transform decision-making in the healthcare space. By seamlessly embedding machine learning methodology into nonlinear mixed-effect models, DeepPumas enables the simultaneous utilization of domain-specific knowledge and available data for model identification.
This workshop will give participants practical skills in hybrid mechanistic and machine learning modeling, a comprehension of how complex covariates can help forecast longitudinal outcomes, and an insight into the possible implications of this technology.
Learning Objectives:
- Learn basic usage of the Pumas and DeepPumas software.
- Understand simple neural networks and how to use them.
- Understand neural-embedded dynamical systems such as Neural Ordinary Differential Equations (ODEs) and Universal Differential Equations (UDEs).
- Learn Mixed-Effect Neural Networks (MeNets) and how to find individualizable models.
- Learn how to integrate machine learning for prognostic factor identification in longitudinal models.
- Understand how to compose all the above to enable a semi-mechanistic scientific machine learning approach to finding individualizable and predictive longitudinal models.
- Get a sense of how this technology may transform the role of data and modeling in the healthcare space.
Instructors: Niklas Korsbo, PhD and Patrick Kofod Mogensen, PhD
Click here to register!
Date & Time: Monday, June 2, 2025 | 8AM – 5PM
Tuesday, June 3 , 2025 | 8AM – 5PM
Workshop 2 : Nonlinear Mixed Effects Modeling Workflows using Pumas
This workshop provides a deep dive into Pumas, a powerful pharmacometric platform designed for modeling and simulation in drug development. Participants will gain hands-on experience and knowledge of the standard workflows in population pharmacokinetics (PK) and sequential PKPD modeling. Experts will guide attendees through various stages of model building, diagnostics, and data wrangling, with opportunities to explore specialized areas like absorption models, using non-Gaussian random effects.
Instructors: Andreas Noack, PhD, Vijay Ivaturi, PhD and Patrick Kofod Mogensen, PhD
Click here to register!
Date & Time: Tuesday, June 3 , 2025 | 9AM – 5PM
Simulations Plus
WORKSHOP 1: Introductory Course for Pharmacometrics Modeling using Monolix
1.5 day: June 2nd (9 AM – 5 PM) and June 3rd (9 AM – 12 PM), 2025
Whether you’re a novice in population modeling eager to start working on your PK and PK-PD projects, or an intermediate modeler aiming to boost your confidence and make strategic decisions, this 1.5-day course is tailored for you. Gain essential skills to: develop, diagnose and interpret models, and efficiently use algorithms within Monolix.
The comprehensive course includes practical, hands-on exercises to reinforce your newly acquired knowledge. No prior experience with MonolixSuite is necessary.
- Gain the statistical knowledge essential for understanding the population approach and interpreting results effectively.
- Build complete Monolix projects, covering data visualization, model set up, and parameter estimation.
- Employ various diagnostic tools to assess model goodness of fit and how to improve it.
- Implement complex models and refine strategies for optimal model development.
- Explore Monolix algorithms and their options.
Includes a temporary licence for the MonolixSuite.
REGISTRATION:
https://simulations-plus.learnupon.com/store/4244916-mx102ip-introductory-course-for-pharmacometrics-modeling-using-monolix
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WORKSHOP 2: Advanced Course for Pharmacometrics Modeling using Monolix
1.5 day: June 2nd (9 AM – 5 PM) and June 3rd (9 AM – 12 PM), 2025
Take your modeling skills to the next level with our advanced 1.5-day course on modeling in pharmacometrics using Monolix. Designed for modelers with intermediate knowledge of Monolix, who wish to:
- Deepen understanding: gain insights into the methods and algorithms behind each task and the impact of their settings.
- Implement complex models: learn how to write and diagnose intricate models effectively such as non-standard parameter-covariate relationships or non-continuous data.
- Optimize model building strategies: improve your approach to covariate model building and inter-occasion variability for enhanced outcomes.
This course features both lectures and interactive hands-on sessions with Monolix. A dedicated Q&A session ensures your queries are addressed comprehensively.
Includes a temporary licence for the MonolixSuite.
REGISTRATION:
https://simulations-plus.learnupon.com/store/4248762-mx300ip-advanced-course-for-pharmacometrics-modeling-using-monolix
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WORKSHOP 3: From Simple to Complex Simulations in Pharmacometrics Course using Simulx
0.5 day: June 3rd (1 – 5 PM), 2025
Explore the world of simulations in pharmacometrics with our half-day workshop using Simulx - a simulation tool equipped with a user-friendly graphical interface and fully integrated with all MonolixSuite applications. This training will give you the keys to confidently set up simulation scenarios and efficiently answer “what if” questions.
Learn the ins and outs of simulations:
- Define simulation elements such as outputs, treatments, or covariates.
- Explore your model and effective dosing regimens.
- Simulate groups of individuals and clinical trials with uncertainty.
- Post-process results and analyse efficacy and safety criteria.
- Use statistical tests to answer relevant questions.
Whether you’re starting from scratch or building a simulation based on an existing Monolix project, this training equips you with the essential tools.
Engage in hands-on sessions, progressing from simple to complex examples, to solidify your understanding of simulations and Simulx. Don't miss this opportunity to enhance your skills and navigate pharmacometrics with ease.
Includes a temporary licence for the MonolixSuite.
REGISTRATION
https://simulations-plus.learnupon.com/store/4248773-sx100ip-from-simple-to-complex-simulations-in-pharmacometrics-using-simulx
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WORKSHOP 4: Automating Pharmacometrics modeling and Simulations Course: Scripting using lixoftConnectorsTM
0.5 day: June 3rd (1 – 5 PM), 2025
Discover the potential of workflow automation in pharmacometrics modeling and simulations with our half-day course on using lixoftConnectors. These R-API functions offer direct access to MonolixSuite applications from within R and enable you to seamlessly script complex workflows and revolutionize your approach to pharmacometrics.
What you will discover:
- R-API functions: gain insight into the applications of lixoftConnectors to access MonolixSuite from R.
- Workflow automation: understand the fundamental principles of these functions and how to script modeling and simulation tasks efficiently.
- Integration of MonolixSuite: learn about benefits from the direct connectivity between R and MonolixSuite through lixoftConnectors.
This course is designed for professionals with at least basic knowledge about Monolix and Simulx, who seek to script their pharmacometrics workflows. It features both lectures and interactive hands-on sessions. Join us to unlock the potential of lixoftConnectors to elevate your pharmacometrics projects.
Includes a temporary licence for the MonolixSuite.
REGISTRATION
https://simulations-plus.learnupon.com/store/4248808-mx201ip-automating-pharmacometrics-modeling-and-simulations-scripting-using-lixoftconnectors
Uppsala University
Automated and scripted model development workshop
Date: Tuesday June 3nd 2025
Time: 09:00 - 17:00
Location: Makedonia Palace, room Aristotelis, Thessaloniki, Greece
Fee: Free (lunch is not included)
Registration: Send an email to rikard.nordgren@uu.se. There is a limited number of seats.
Workshop instructors: Dr. Xiaomei Chen, Rikard Nordgren (Systems developer), Stella Belin (Systems developer), Prof. Mats Karlsson, Prof. Andrew Hooker
Pharmpy is an open-source pharmacometric library for automated and scripted model building. By using Pharmpy, you can build pharmacometric workflows in R or Python, including creating and fitting models, parsing modelfit results, and running full tools for automatic model building. This one day course will let participants get familiar with the different functions and tools, as well as some hands-on experience with the software. Pharmpy mainly supports building NONMEM models with some support for building nlmixr models. Please visit https://pharmpy.github.io for more information on the package. A paper was published on the automatic model building tool (https://pubmed.ncbi.nlm.nih.gov/39190006/) and Pharmpy has been presented at previous PAGE conferences (https://www.page-meeting.org/default.asp?abstract=11039).
Contents:
* Background and philosophy of the automatic model building tools
* Scripted model building (including modifying existing NONMEM models and creating models from scratch)
* Automatic model building of the structural, IIV, IOV, RUV and covariate models
* Full automatic model building starting from a dataset (PK, PKPD, drug-metabolite and TMDD models)
* Hands-ons to explore how the tools work
* Insights into the inner workings of the tools
Examples and hands-ons will be using R.
Practical Tools for Model Calibration with SimBiology®
Date: June 3, 2025
Time: 8:30am-12:30pm EEST
Mathematical modeling such as (PB)PK/PD and QSP is becoming increasingly important to inform decision making in various stages of the drug development process. These models often take the form of ordinary differential equations and include numerous parameters that need to be estimated with experimental data. The process of model calibration presents many challenges such as the difficulty to assess parameter identifiability, scarcity of high-quality experimental data, and highly nonlinear objective functions with multiple local optima.
In this workshop, we will cover a workflow for model calibration in SimBiology®, which encompasses methods for parameter selection, data fitting, and parameter identifiability analysis. These techniques, when used in sequence, establish a comprehensive approach for effective model calibration.
We will provide a theoretical background for each of these steps and offer step-by-step hands-on exercises to build up a full model calibration workflow derived from a real-world example.
Highlights:
- Review methods for parameter selection including feature ranking and global sensitivity analysis (GSA) with SimBiology and leverage the results to select a subset of model parameters for estimation.
- Learn the difference between local and global optimization methods and the reasons why global solvers are often preferred for fitting data.
- Use the Profile likelihood method to detect parameter non-identifiability.
To maximize your experience in this workshop, we recommend having some prior experience with SimBiology. A basic knowledge will help you engage more fully with the material presented.
This workshop is free of charge for all attendees, but registration is required.
State of the Art in Model Informed in Drug and Generics Development
SEMINAR: 3rd June 2025, 9.00 am
VENUE: TBA
Summary
This seminar is intended for academics, students or scientists working in pharmaceutical industries, regulatory agencies, and contract research organizations.
To view the full program, click here
To register, please contact ctheodosi@afeacongress.gr