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Diplôme d’Université Pharmacometrics Modeling

Graduate education

120 heures
4850 €

Dates de formation

Référence FCS18-0106A :
du 01/04/2019 au 31/01/2020

See content for modules schedule

Lieu de la formation

Université de Strasbourg - Service Formation Continue

21 Rue du Maréchal Lefebvre,
67100 Strasbourg
France

Renseignements & inscriptions

Frédérique COSTES

21 Rue du Maréchal Lefebvre 67100 Strasbourg, France
03 68 85 49 27

Sauf le mercredi après-midi et le vendredi

03 68 85 49 29
f.costes@unistra.fr

Context

Pharmacometrics is a modeling and simulation (M&S) tool to support decision making during the drug development process from preclinical to clinical studies. M&S facilitates the continuous integration of available information related to a drug or disease into constantly-evolving mathematical models capable of describing and predicting the behavior of studied systems to address the questions researchers, regulators, and public health care bodies face when bringing drugs to patients

This diploma used to train scientists in Quantitative clinical Pharmacology and in particular to PK-PD modeling, by using Pharmacokinetics and Pharmacodynamics knowledge in different therapeutic areas, such as oncology and cardiovascular diseases, to understand and optimize treatments according to clinical responses (dosage individualization) and to facilitate decision-making during the drug development process.

Prospectives attendees

Pharmacists, pharmacologists, physicians, veterinarians, statisticians, engineers, scientists from academy, hospital or industry.

Professionals with a master or doctoral degree with some experience in medical product development who aspire to transform into decision-making pharmacometricians or quantitative translational scientists should apply.

The program is designed for professionals with full- or part-time jobs in areas such as pharmacology, engineering, statistics, pharmaceutical and medical sciences and epidemiology.

Compétences à l'issue de la formation

  • Identify proper class of PK/PD models to describe different PK/PD relationships.
  • Use software mainly in Pharmacometrics.
  • Create, manipulate and manage Nonmem dataset and Develop a Modeling & Simulation framework.
  • Interpret results in order to suggest answer to stakeholder.
  • Develop Population PK/PD analysis and PK/PD modeling and Use R-Pharma in various situations.
  • Create own PK/PD concept in clinical practice and/or in drug development.

Content

Module 1: Pharmacokinetics/Pharmacodynamics (PK/PD), as integral components of the drug development process 

Session by e-learning (30 hours) – From 1st to 30 April 2019

  • Introduction to Drug Development process
  • Principles of PK/PD relationships and PKPD modeling
  • Principles of clinical pharmacology and their applications to clinical development in oncology and cardiovascular diseases
  • Module 2 : Pharmacometrics : modeling and simulation tools 

    (5 days). From 17 to 21 June 2019

  • Introduction to pharmacokinetics modeling, the NONMEM suite, modeling strategy, model building and validation, Monte Carlo simulation, PKPD analysis.
  • Initiation to software R for Pharmacometrics
  • Application of M&S will be on cardiovascular and oncology therapeutic areas. 
  • Module 3 : Concepts of PK/PD modeling 

    Session by e-learning (20 hours). October 2019

  • PK-PD link models  
  • Population PK/PD analysis
  • Intermediate and more complex PKPD modeling 
  • Understand and learn using R Pharma software in complex situations
  • Module 4 : PK/PD modeling based drug development approach 

    (5 days). January 2020

  • Applications to PKPD analysis and modeling on oncology and cardiovascular or other therapeutic areas
  • Create own PK/PD concept, analyze it, and establish a M&S system by establishing a project of clinical practice and/or in drug development.
  • Teaching methods

    All courses will be in English, modules 1 and 3 are delivered by e-learning

    The hands on learning sessions with software and interface on PCs  (modules 2 and 4) will take place in Strasbourg

    The e-learning sessions will be held on the DigitalUni platform specifically developed for continuing education. For technical information and prerequisites, please contact sfc-ead@unistra.fr

    Validation

    After each module, a certificate of attendance is delivered and a notation is given (continuous control).

    This graduate education in Pharmacometrics Modeling from the University of Strasbourg will be delivered after validation of the 4 modules and after writing a project about a specific case chosen by the student, using M&S tool  and PK-PD modeling.

    Study Directors

    Dr Geneviève Ubeaud-Séquier, Professor of Pharmacokinetics in Faculty of Pharmacy and Hospital Pharmacist – Strasbourg University 

    e-mail : ubeaud@unistra.fr  

    In collaboration with international experts in M&S field

    Informations

    This training course is an “action d’adaptation et de développement des compétences” (ref. French law). A certificate of attendance is delivered after the course. An evaluation measures the trainees’ satisfaction and the achievement of learning objectives.

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