European Medicines Agency-European Federation of Pharmaceutical Industries and Associations modelling and simulation workshop

• Date:
  Wednesday, 30 November 2011, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

The objective of the workshop is to discuss the role and scope of modelling and simulation in drug-development both from the developer's and the regulator's perspectives.

Documents

Agenda – European Medicines Agency-European Federation of Pharmaceutical Industries and Associations modelling and simulation workshop

Reference Number: EMA/455573/2011

European Federation of Pharmaceutical Inudustries and Associations-European Medicines Agency modelling and simulation workshop report

Reference Number: EMA/238961/2012

Break-out session 1 report - Modelling and simulation in early development

Reference Number: EMA/143473/2012

Break-out session 2 report - Modelling and simulation in clinical pharmacology and dose finding

Reference Number: EMA/143475/2012

Break-out session 3 report - Modelling and simulation as a tool to bridge efficacy and safety data in special populations

Reference Number: EMA/143471/2012

Break-out session 4 report - Modelling and simulation to optimise the design of confirmatory trials, to analyse phase 3 data and to characterise risk-benefit and support label claims

Reference Number: EMA/143476/2012

Presentation - Current position and expectation for use of modelling and simulation in drug development and regulatory decision making

Presentation - Role of modelling and simulation in regulatory decision making in Europe

Presentation - Impact of pharmacometric analysis on drug approvals and therapeutics

Presentation - Current position and expectation for use of modelling and simulation in drug development and regulatory decision making: The Pharmaceuticals and Medical Devices Agency viewpoint

Presentation - Modelling and simulation examples that failed or succeeded to meet regulators regulators’ expectations

Presentation - Modelling and simulation examples that failed to meet regulator's expectations

Presentation - Levels of evidence in drug development: Paediatric dose selection for fondaparinux

Agenda - European Medicines Agency-European Federation of Pharmaceutical Industries and Associations modelling and simulation workshop - Break-out session 1

Reference Number: EMA/926026/2011

Presentation - Break-out session 1 regulatory expectations

Presentation - Modelling and simulation in preclinical development: Predicting thyroid hormone side effects in humans from preclinical toxicity studies - Break-out session 1 theme 1

Presentation - Utility of preclinical pharmacokinetic-pharmacodynamic modelling in QT safety testing - Break-out session 1 theme 1

Presentation - Regulatory discussant - Break-out session 1 theme 1

Presentation - Modelling and simulation support for design of first-in-man studies: the minimum acceptable biological effect level (MABEL) approach - Break-out session 1 theme 2

Presentation - Regulatory discussant - Break-out session 1 theme 2

Presentation - Collaborative data resources: TIPharma pharmacokinetic-pharmacodynamic modelling platform - Break-out session 1 theme 3

Presentation - Quantitative systems pharmacology in drug development - A pharma perspective - Break-out session 1 theme 3

Presentation - Integration of multiple biomarkers, translation to surrogate / outcomes and their application in early drug development – A case study to support phase IIa design - Break-out session 1 theme 3

Presentation - Pharmacokinetic-pharmacodynamic modelling to support go / no-go decisions for a novel gp120 inhibitor - Break-out session 1 theme 3

Presentation - Phase 2b dose selection, leveraging comparator data through multidisciplinary modelling and simulation - Break-out session 1 theme 3

Presentation - Regulatory discussant - Break-out session 1 theme 3

Agenda - European Medicines Agency-European Federation of Pharmaceutical Industries and Associations modelling and simulation workshop - Break-out session 2

Reference Number: EMA/926027/2011

Presentation - Dose–exposure–response relationships: the basis of effective dose-regimen selection - Break-out session 2 theme 1

Presentation - Dose–exposure-response relationship - Break-out session 2 theme 1

Presentation - Dose finding under model uncertainty – A case study based on a multi-regional clinical trial - Break-out session 2 theme 1

Presentation - Design of a model based dose-finding study in diabetes - Break-out session 2 theme 2

Presentation - Case study title: Improvement of clinical benefit for a sub-sub-group of paediatric systemic juvenile idiopathic arthritis patients utilising model-based dose adjustment optimisation (Roche #4) - Break-out...

Presentation - The integration of data (e.g. across studies or clinical and in-vitro data) using modelling and simulation along with reasonable assumptions can provide evidence for evaluation of efficacy / safety risks w...

Presentation - Integration of data using modelling and simulation can provide evidence for evaluation of efficacy-safety risks without the need for a separate study - Break-out session 2 theme 2

Presentation - Modelling and simulation for dose adjustment in renally impaired patients - Break-out session 2 theme 2

Presentation - Assessing the probability of drug-induced QTc-interval prolongation during early clinical drug development - Break-out session 2 theme 2

Agenda - European Medicines Agency-European Federation of Pharmaceutical Industries and Associations modelling and simulation workshop - Break-out session 3

Reference Number: EMA/926028/2011

Presentation - Evidence synthesis in drug development for special populations, ethnic groups and rare diseases - Break-out session 3

Presentation - Views of the Paediatric Committee and European Medicines Agency paediatric medicines on discussing and using modelling and simulation as a tool to bridge pharmacokinetics, efficacy and safety data - Break-...

Presentation - Assumption setting in a semi-mechanistic population pharmacokinetic-pharmacodynamic model across a wide range of patients - Break-out session 3 theme 1

Presentation - Regulatory discussant: Case 1 - Break-out session 3 theme 1

Presentation - Revatio in paediatric pulmonary arterial hypertension, an orphan indication - Break-out session 3 theme 2

Presentation - Modelling and simulation support to the bridging of a drug with ethnic pharmacokinetic differences - Break-out session 3 theme 2

Presentation - Regulatory discussant - Discussion: sildenafil case - Break-out session 3 theme 2

Presentation - Evaluation of fixed dose combination in paediatric indications - Use of pharmacokinetic briding across ethnic groups - Break-out session 3 theme 3

Presentation - Case study title: Evaluation of fixed-dose combinations in paediatric indications - Use of pharmacokinetic bridging - Break-out session 3 theme 3

Presentation - Pharmacokinetic-pharmacodynamic assessment of topiramate dosing regimens for children with epilepsy 2 to less than 10 years of age - Break-out session 3 theme 4

Presentation - Case study: Sample size estimation for a paediatric clinical trial utilising external information from historical trials in adults and children - Break-out session 3 theme 4

Presentation - Some statistical issues of modelling and extrapolation - Break-out session 3 theme 4

Presentation - Pharmacokinetic-pharmacodynamic assessment of topiramate dosing regimens for children with epilepsy 2 to less than 10 years of age - Break-out session 3 theme 4

Agenda - European Medicines Agency-European Federation of Pharmaceutical Industries and Associations modelling and simulation workshop - Break-out session 4

Reference Number: EMA/926029/2011

Presentation - Modelling and simulation to optimise the design of confirmatory trials, to analyse phase 3 data and to characterise risk-benefit and support label claims - Break-out session 4

Presentation - Modelling and simulation to optimise the design of confirmatory trials - Break-out session 4 theme 1

Presentation - Regulatory comments - Break-out session 4 themes 1 and 3

Presentation - Longitudinal model-based test as primary analysis in phase III - Break-out session 4 theme 2

Presentation - Mixed-effect models for trials of disease-modifying treatments - Break-out session 4 theme 2

Presentation - Rob Hemmings preliminary comments - Break-out session 4 theme 2

Presentation - Modelling and simulation to characterise risk-benefit and support label claims - Break-out session 4 theme 3

Presentation - Regulatory comments - Break-out session 4 themes 1 and 3

Presentation - Modelling to guide regulatory guidelines and decision making during development - Break-out session 4 theme 3

Presentation - Regulatory discussant: Rob Hemmings preliminary conclusions - Break-out session 4 theme 3

Presentation - Outcomes from break-out session 1

Presentation - Outcomes from break-out session 2

Presentation - Modelling and simulation as a tool to bridge pharmacokinetics, efficacy and safety data in special populations, ethnic groups and rare diseases - Break-out session 3

Presentation - Modelling and simulation to optimise the design of confirmatory trials, to analyse phase 3 data and to characterise risk-benefit and support label claims - Break-out session 4 plenary feedback

Presentation - Approaching the Agency - Session 7

Presentation - Summary and future steps: European Federation of Pharmaceutical Industries and Associations perspectives - Session 7

Presentation - Modelling and simulation good practices and next steps - Session 7

Multimedia