Workshop on qualification and reporting of physiologically-based pharmacokinetic (PBPK) modelling and simulation

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Date: Lundi, 21 novembre 2016, Journée Entière
Emplacement: European Medicines Agency, Amsterdam, the Netherlands

The workshop provides an opportunity to discuss comments received on the draft guideline on PBPK modelling and simulation during public consultation (this consultation is open until 31 January 2017), explain its key messages and provide more details on qualification procedures and evaluation of drug models. It will also aim to communicate EMA's current thinking on the utility of PBPK to stakeholders from other regulatory agencies, the pharmaceutical industry, academia, patient representatives and software developers.

Documents

Programme - EMA workshop on qualification and reporting of physiologically-based pharmacokinetic (PBPK) modelling and simulation

English (EN) (316.04 Ko - PDF)

Première publication: 07/10/2016 Dernière mise à jour: 17/11/2016

Registration of interest – EMA workshop on qualification and reporting of physiologically-based pharmacokinetic (PBPK) modelling and simulation (deadline 31 October)

English (EN) (375.33 Ko - PDF)

Première publication: 07/10/2016 Dernière mise à jour: 11/10/2016

Presentation - Introduction of the PBPK Guideline and expectations of the day (Anna Nordmark)

English (EN) (752.88 Ko - PDF)

Première publication: 05/12/2016 Dernière mise à jour: 05/12/2016

Presentation - CHMP qualification of novel methodologies (Efthymios Manolis)

English (EN) (2.29 Mo - PDF)

Première publication: 05/12/2016 Dernière mise à jour: 05/12/2016

Presentation - Feedback to the draft guideline on qualification and reporting of PBPK modelling and simulation (N. Parrott)

English (EN) (741.31 Ko - PDF)

Première publication: 05/12/2016 Dernière mise à jour: 05/12/2016

Presentation - Qualification of the PBPK platform for the Intended Purpose: EFPIA comments overview (S. Y. Amy Cheung and Solange Rohou)

English (EN) (1.51 Mo - PDF)

Première publication: 05/12/2016 Dernière mise à jour: 05/12/2016

Presentation - EMA Guideline on the qualification and reporting of physiologically based pharmacokinetic (PBPK) modeling and simulation (Viera Lukacova)

English (EN) (158.96 Ko - PDF)

Première publication: 05/12/2016 Dernière mise à jour: 05/12/2016

Presentation - Qualification of the Simcyp platform for the intended purposes(Masoud Jamei)

English (EN) (1.47 Mo - PDF)

Première publication: 05/12/2016 Dernière mise à jour: 05/12/2016

Presentation - Qualification of PBPK platform – experience with PK-Sim (Michael Block)

English (EN) (3.07 Mo - PDF)

Première publication: 05/12/2016 Dernière mise à jour: 05/12/2016

Presentation - PBPK for Paediatric Development (R. Burghaus)

English (EN) (2.59 Mo - PDF)

Première publication: 05/12/2016 Dernière mise à jour: 05/12/2016

Presentation - Reporting and evaluation of predictive performance - what is missing in submissions today? (Sue Cole)

English (EN) (436.23 Ko - PDF)

Première publication: 05/12/2016 Dernière mise à jour: 05/12/2016

Presentation - Application of physiologically-based pharmacokinetic modeling to support dosing recommendations – The US Food and Drug Administration Experience (Ping Zhao)

English (EN) (910.28 Ko - PDF)

Première publication: 05/12/2016 Dernière mise à jour: 05/12/2016

Presentation - Sensitivity (Leon Aarons)

English (EN) (520.73 Ko - PDF)

Première publication: 05/12/2016 Dernière mise à jour: 05/12/2016

Presentation - Uncertainty quantification (Ine Skottheim Rusten)

English (EN) (334.76 Ko - PDF)

Première publication: 05/12/2016 Dernière mise à jour: 05/12/2016

Presentation - Overview of comments on the guideline received so far and a summary of major areas that require attention (Eva Gil Berglund)

English (EN) (808.28 Ko - PDF)

Première publication: 05/12/2016 Dernière mise à jour: 05/12/2016

Questions to panel on qualification of the PBPK platform for the intended purpose

English (EN) (63.68 Ko - PDF)

Première publication: 05/12/2016 Dernière mise à jour: 05/12/2016

Presentation - Questions to panel on reporting and evaluation of predictive performance

English (EN) (63.84 Ko - PDF)

Première publication: 05/12/2016 Dernière mise à jour: 05/12/2016

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