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
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 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
- 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 1 April.
Register now to expand your PBPK expertise - early bird discounts available!
For more information and registration visit Pharmetheus.com – Workshop: PBPK modeling for First-in-Human & DDI
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
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
Simulation 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.