Workshops

Join us for hands-on PBPK modeling, Quantitative Systems Pharmacology (QSP), and population PK/PD data analyses training near you. Space is limited, so register soon!

Research Triangle Park, NC

Sep 11-12, 2019

Research Triangle Park, North Carolina

DILIsym® 2-Day Training Workshop

This is a beginner’s course for clinicians, pharmaceutical/biotechnology scientists, and engineers in the areas of toxicology, clinical pharmacology, pharmacovigilance, DMPK and ADME - prior experience with DILIsym is not required. The course will use DILIsym, but the guiding principles will be taught in a software-independent manner.

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Mainz, Germany

The 3-Day Introductory Workshop in Population PK Data Analysis with NONMEM®
Sep 23-25, 2019

Mainz, Germany

The 3-Day Introductory Workshop in Population PK Data Analysis with NONMEM®

This three-day workshop has been designed to provide the necessary information to successfully implement population pharmacokinetic methodology in a drug development program and to provide the foundation for understanding the basics of NONMEM coding and interpretation of NONMEM output. The material is structured to impart both the theoretical and practical aspects of the population approach and is versatile so that participants with diverse backgrounds and areas of expertise may benefit. Examples of the use of population PK studies in drug development programs will be presented to provide specific details of various implementations and better illustrate essential aspects of population PK methods. Participants will gain an appreciation for the importance of accurate and sufficient data collection and learn how to proactively plan in order to maximize study effectiveness. Throughout the workshop, the presenters will provide examples from their experience to inform best practices for implementation and avoiding problems. Emphasis will be placed on compliance with the FDA’s Guidance for Industry on Population PK and the EMA’s Guideline on Reporting the Results of Population PK Analyses.

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Introductory GastroPlus® Simulation & Modeling Workshop
Sep 23-25, 2019

Mainz, Germany

Introductory GastroPlus® Simulation & Modeling Workshop

This is a beginner’s course – prior experience with GastroPlus is not required. This course was designed for; Pharmaceutical & biotechnology scientists/engineers in DMPK, ADME, preformulation/formulation, biopharmaceutics, pharmacokinetics and clinical pharmacology and Scientists involved in drug development wishing to learn how to apply our simulation and modeling tools to accelerate drug discovery and development.

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Advanced GastroPlus® DMPK & Clinical Pharmacology Workshop
Sep 26-27, 2019

Mainz, Germany

Advanced GastroPlus® DMPK & Clinical Pharmacology Workshop

This is an advanced course – a prerequisite is familiarity with setting up and running basic GastroPlus simulations, including database & support file structures, basic inputs for physicochemical & pharmacokinetic parameters, and basic physiology options for human & animal simulations. This course was designed for scientists working in; Preclinical pharmacokinetics & pharmacodynamics, Clinical pharmacokinetics & pharmacodynamics, Past GastroPlus workshop attendees have commented that the interaction & networking among industry, government, and academic scientists is an important and valuable part of the experience!

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Advanced GastroPlus® Pharmaceutical Development Workshop
Sep 26-27, 2019

Mainz, Germany

Advanced GastroPlus® Pharmaceutical Development Workshop

This is an advanced course – a prerequisite is familiarity with setting up and running basic GastroPlus simulations, including database & support file structures, basic inputs for physicochemical & pharmacokinetic parameters, and basic physiology options for human & animal simulations. This course was designed for scientists & engineers working in pharmaceutical development who need an in-depth understanding of how formulation affects the highly interactive processes of: dissolution, precipitation, gastrointestinal transit, absorption (passive and carrier-mediated), first-pass metabolism, pharmacokinetics. Past GastroPlus workshop attendees have commented that the interaction & networking among industry, government, and academic scientists is an important and valuable part of the experience!

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Orlando, Florida

Applying MAM/PBPK Modeling to Predict Positive/Negative Food Effects: Approaches and Special Considerations
Oct 19, 2019

Orlando, Florida

Applying MAM/PBPK Modeling to Predict Positive/Negative Food Effects: Approaches and Special Considerations

The focus of this complimentary ½-day workshop will be to discuss how physiological differences between fasted and fed states have been incorporated into mechanistic absorption (MAM) and physiologically-based pharmacokinetic (PBPK) models to predict positive and negative food effects. A combination of presentations and interactive examples using the GastroPlus® PBPK modeling platform will illustrate how to parameterize baseline models for several drugs under fasted conditions and, once validated, how they can be applied to (i) predict the changes in pharmacokinetics when drug is administered with food and (ii) optimize formulations to mitigate exposure differences. Gaps in the current methods and approaches will also be explored. This workshop is FREE for ACoP attendees only.

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Optimization of Exposure, Safety, and Efficacy through Modeling and Simulation: a Simulations Plus workshop on machine learning + PBPK (GastroPlus), PKPD modeling (KIWI), QSP (NAFLDsym), and QST (DILIsym)
Oct 20, 2019

Orlando, Florida

Optimization of Exposure, Safety, and Efficacy through Modeling and Simulation: a Simulations Plus workshop on machine learning + PBPK (GastroPlus), PKPD modeling (KIWI), QSP (NAFLDsym), and QST (DILIsym)

Modeling and simulation (M&S) is now a critical activity within the drug development process. The Simulations Plus family of companies has a wide range of experience and tools available to enable effective M&S. This workshop will provide a background knowledge of multiple M&S approaches and describe how Simulations Plus has partnered with developers to help facilitate better decisions and smarter investments. This workshop will provide an excellent foundation for those looking to learn more about various types of M&S approaches, as well as those looking for implementable solutions. This workshop is FREE for all attendees.

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