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
English (EN) (139.3 KB - PDF)
European Federation of Pharmaceutical Inudustries and Associations-European Medicines Agency modelling and simulation workshop report
English (EN) (109.63 KB - PDF)
Break-out session 1 report - Modelling and simulation in early development
English (EN) (60.05 KB - PDF)
Break-out session 2 report - Modelling and simulation in clinical pharmacology and dose finding
English (EN) (61.27 KB - PDF)
Break-out session 3 report - Modelling and simulation as a tool to bridge efficacy and safety data in special populations
The development, registration and approval of novel medicines have traditionally been based on evidence arising from (large) prospective trials. Such an evidence-based approach is often unsuitable to evaluate benefit/risk (B/R) in special populations, ethnic groups or rare diseases.
English (EN) (81.89 KB - PDF)
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
BOS4 was dedicated to discussing how companies and the EMA view the use of M&S in the design and interpretation of Phase 3 studies. The EMA was interested in how EPFIA intends to apply M&S in the confirmatory /risk benefit setting in the future.
English (EN) (67.35 KB - PDF)
Presentation - Current position and expectation for use of modelling and simulation in drug development and regulatory decision making
English (EN) (448.85 KB - PDF)
Presentation - Role of modelling and simulation in regulatory decision making in Europe
English (EN) (272.05 KB - PDF)
Presentation - Impact of pharmacometric analysis on drug approvals and therapeutics
English (EN) (1.34 MB - PDF)
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
English (EN) (66.44 KB - PDF)
Presentation - Modelling and simulation examples that failed or succeeded to meet regulators regulators’ expectations
English (EN) (448.69 KB - PDF)
Presentation - Modelling and simulation examples that failed to meet regulator's expectations
English (EN) (118.61 KB - PDF)
Presentation - Levels of evidence in drug development: Paediatric dose selection for fondaparinux
English (EN) (708.65 KB - PDF)
Agenda - European Medicines Agency-European Federation of Pharmaceutical Industries and Associations modelling and simulation workshop - Break-out session 1
English (EN) (119.93 KB - PDF)
Presentation - Break-out session 1 regulatory expectations
English (EN) (40.38 KB - PDF)
Presentation - Modelling and simulation in preclinical development: Predicting thyroid hormone side effects in humans from preclinical toxicity studies - Break-out session 1 theme 1
English (EN) (824.31 KB - PDF)
Presentation - Utility of preclinical pharmacokinetic-pharmacodynamic modelling in QT safety testing - Break-out session 1 theme 1
English (EN) (991.36 KB - PDF)
Presentation - Regulatory discussant - Break-out session 1 theme 1
English (EN) (62.19 KB - PDF)
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
English (EN) (1.32 MB - PDF)
Presentation - Regulatory discussant - Break-out session 1 theme 2
English (EN) (53.89 KB - PDF)
Presentation - Collaborative data resources: TIPharma pharmacokinetic-pharmacodynamic modelling platform - Break-out session 1 theme 3
English (EN) (731.5 KB - PDF)
Presentation - Quantitative systems pharmacology in drug development - A pharma perspective - Break-out session 1 theme 3
English (EN) (538.97 KB - PDF)
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
English (EN) (733.53 KB - PDF)
Presentation - Pharmacokinetic-pharmacodynamic modelling to support go / no-go decisions for a novel gp120 inhibitor - Break-out session 1 theme 3
English (EN) (318.01 KB - PDF)
Presentation - Phase 2b dose selection, leveraging comparator data through multidisciplinary modelling and simulation - Break-out session 1 theme 3
English (EN) (702.05 KB - PDF)
Presentation - Regulatory discussant - Break-out session 1 theme 3
English (EN) (271.37 KB - PDF)
Agenda - European Medicines Agency-European Federation of Pharmaceutical Industries and Associations modelling and simulation workshop - Break-out session 2
English (EN) (114.3 KB - PDF)
Presentation - Dose–exposure–response relationships: the basis of effective dose-regimen selection - Break-out session 2 theme 1
English (EN) (134.59 KB - PDF)
Presentation - Dose–exposure-response relationship - Break-out session 2 theme 1
English (EN) (284.3 KB - PDF)
Presentation - Dose finding under model uncertainty – A case study based on a multi-regional clinical trial - Break-out session 2 theme 1
English (EN) (446.27 KB - PDF)
Presentation - Design of a model based dose-finding study in diabetes - Break-out session 2 theme 2
English (EN) (86.81 KB - PDF)
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...
English (EN) (361.9 KB - PDF)
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...
English (EN) (2.82 MB - PDF)
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
English (EN) (338.3 KB - PDF)
Presentation - Modelling and simulation for dose adjustment in renally impaired patients - Break-out session 2 theme 2
English (EN) (629.63 KB - PDF)
Presentation - Assessing the probability of drug-induced QTc-interval prolongation during early clinical drug development - Break-out session 2 theme 2
English (EN) (1.63 MB - PDF)
Agenda - European Medicines Agency-European Federation of Pharmaceutical Industries and Associations modelling and simulation workshop - Break-out session 3
English (EN) (144.79 KB - PDF)
Presentation - Evidence synthesis in drug development for special populations, ethnic groups and rare diseases - Break-out session 3
English (EN) (589.24 KB - PDF)
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-...
English (EN) (47.48 KB - PDF)
Presentation - Assumption setting in a semi-mechanistic population pharmacokinetic-pharmacodynamic model across a wide range of patients - Break-out session 3 theme 1
English (EN) (763.97 KB - PDF)
Presentation - Regulatory discussant: Case 1 - Break-out session 3 theme 1
English (EN) (392.66 KB - PDF)
Presentation - Revatio in paediatric pulmonary arterial hypertension, an orphan indication - Break-out session 3 theme 2
English (EN) (2.18 MB - PDF)
Presentation - Modelling and simulation support to the bridging of a drug with ethnic pharmacokinetic differences - Break-out session 3 theme 2
English (EN) (466.53 KB - PDF)
Presentation - Regulatory discussant - Discussion: sildenafil case - Break-out session 3 theme 2
English (EN) (18.5 KB - PDF)
Presentation - Evaluation of fixed dose combination in paediatric indications - Use of pharmacokinetic briding across ethnic groups - Break-out session 3 theme 3
English (EN) (739.33 KB - PDF)
Presentation - Case study title: Evaluation of fixed-dose combinations in paediatric indications - Use of pharmacokinetic bridging - Break-out session 3 theme 3
English (EN) (574.42 KB - PDF)
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
English (EN) (735.33 KB - PDF)
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
English (EN) (102.8 KB - PDF)
Presentation - Some statistical issues of modelling and extrapolation - Break-out session 3 theme 4
English (EN) (355.22 KB - PDF)
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
English (EN) (1.18 MB - PDF)
Agenda - European Medicines Agency-European Federation of Pharmaceutical Industries and Associations modelling and simulation workshop - Break-out session 4
English (EN) (131.47 KB - PDF)
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
English (EN) (719.63 KB - PDF)
Presentation - Modelling and simulation to optimise the design of confirmatory trials - Break-out session 4 theme 1
English (EN) (529 KB - PDF)
Presentation - Regulatory comments - Break-out session 4 themes 1 and 3
English (EN) (174.48 KB - PDF)
Presentation - Longitudinal model-based test as primary analysis in phase III - Break-out session 4 theme 2
English (EN) (446.27 KB - PDF)
Presentation - Mixed-effect models for trials of disease-modifying treatments - Break-out session 4 theme 2
English (EN) (574.33 KB - PDF)
Presentation - Rob Hemmings preliminary comments - Break-out session 4 theme 2
English (EN) (31.01 KB - PDF)
Presentation - Modelling and simulation to characterise risk-benefit and support label claims - Break-out session 4 theme 3
English (EN) (455.29 KB - PDF)
Presentation - Regulatory comments - Break-out session 4 themes 1 and 3
English (EN) (174.48 KB - PDF)
Presentation - Modelling to guide regulatory guidelines and decision making during development - Break-out session 4 theme 3
English (EN) (415.04 KB - PDF)
Presentation - Regulatory discussant: Rob Hemmings preliminary conclusions - Break-out session 4 theme 3
English (EN) (21.29 KB - PDF)
Presentation - Outcomes from break-out session 1
English (EN) (322.91 KB - PDF)
Presentation - Outcomes from break-out session 2
English (EN) (235.45 KB - PDF)
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
English (EN) (712.86 KB - PDF)
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
English (EN) (748.43 KB - PDF)
Presentation - Approaching the Agency - Session 7
English (EN) (131.03 KB - PDF)
Presentation - Summary and future steps: European Federation of Pharmaceutical Industries and Associations perspectives - Session 7
English (EN) (10.34 KB - PDF)
Presentation - Modelling and simulation good practices and next steps - Session 7
English (EN) (49.82 KB - PDF)
Multimedia
Contact point
Andriani Drouza
modsim11@ema.europa.eu