Workshop on paediatric investigation plans in type-2 diabetes mellitus

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Date: Pirmdiena, 25 Februāris 2013, Visu dienu
Vieta: European Medicines Agency, Amsterdam, the Netherlands

This workshop focuses on aspects of paediatric clinical trials in type-2 diabetes mellitus (T2DM). Experts in the field, together with regulators and the pharmaceutical industry discuss suitable inclusion criteria, outcome measures and study designs in paediatric investigation plans in T2DM and approaches to enhance trial feasibility. Expressions of interest to be sent by 11/02/2013. Registration by invitation only.

Documents

Agenda - Agenda and list of questions for the workshop on paediatric investigation plans in type-2 diabetes mellitus

English (EN) (127.14 KB - PDF)

Pirmo reizi publicēts: 03/05/2013 Pēdējo reizi atjaunināts: 03/05/2013

Report - The workshop on paediatric investigation plans in type-2 diabetes mellitus

English (EN) (215.2 KB - PDF)

Pirmo reizi publicēts: 03/05/2013 Pēdējo reizi atjaunināts: 03/05/2013

Presentation - Objectives and problem statement (Janina Karres)

English (EN) (89.77 KB - PDF)

Pirmo reizi publicēts: 03/05/2013 Pēdējo reizi atjaunināts: 03/05/2013

Presentation - Clinical Practice Consensus Guidelines International Society for Pediatric and Adolescent Diabetes

English (EN) (1.27 MB - PDF)

Pirmo reizi publicēts: 03/05/2013 Pēdējo reizi atjaunināts: 03/05/2013

Presentation - Type-2 diabetes in children and adolescents (William Tamborlane)

English (EN) (256.28 KB - PDF)

Pirmo reizi publicēts: 03/05/2013 Pēdējo reizi atjaunināts: 03/05/2013

Presentation - Type-2-diabetes-paediatric-investigation-plan overview (Janina Karres)

English (EN) (104.77 KB - PDF)

Pirmo reizi publicēts: 03/05/2013 Pēdējo reizi atjaunināts: 03/05/2013

Presentation - Study recruitment issues (Phillip Ambery)

English (EN) (743.04 KB - PDF)

Pirmo reizi publicēts: 03/05/2013 Pēdējo reizi atjaunināts: 03/05/2013

Presentation - Questionnaire overview (Janina Karres)

English (EN) (129.85 KB - PDF)

Pirmo reizi publicēts: 03/05/2013 Pēdējo reizi atjaunināts: 03/05/2013

Presentation - The European Network of Paediatric Research (Peter Helms)

English (EN) (485.91 KB - PDF)

Pirmo reizi publicēts: 03/05/2013 Pēdējo reizi atjaunināts: 03/05/2013

Presentation - Innovative trial approaches (David Dunger, Ronald Portman, James Wason, Jack Bowden)

English (EN) (84.43 KB - PDF)

Pirmo reizi publicēts: 03/05/2013 Pēdējo reizi atjaunināts: 03/05/2013

Presentation - Meta-analysis

English (EN) (100.85 KB - PDF)

Pirmo reizi publicēts: 03/05/2013 Pēdējo reizi atjaunināts: 03/05/2013

Presentation - Pharmacometric approaches for extrapolation from adult to paediatric type-2 diabetes mellitus (Tarek Leil, Satyendra Suryawanshi, Ronald Portman)

English (EN) (996.93 KB - PDF)

Pirmo reizi publicēts: 03/05/2013 Pēdējo reizi atjaunināts: 03/05/2013

Presentation - Workshop on paediatric investigation plans in type-2 diabetes mellitus - conclusions (Paolo Tomasi)

English (EN) (338.21 KB - PDF)

Pirmo reizi publicēts: 03/05/2013 Pēdējo reizi atjaunināts: 03/05/2013

Agenda - Agenda and list of questions for the workshop on paediatric investigation plans in type-2 diabetes mellitus

Draft Reference Number: EMA/36057/2013

English (EN) (91.16 KB - PDF)

Pirmo reizi publicēts: 29/01/2013 Pēdējo reizi atjaunināts: 29/01/2013