Workshop on paediatric investigation plans in type-2 diabetes mellitus

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Date: Lundi, 25 février 2013, Journée Entière
Lieu: 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 Ko - PDF)

Première publication: 03/05/2013 Dernière mise à jour: 03/05/2013

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

English (EN) (215.2 Ko - PDF)

Première publication: 03/05/2013 Dernière mise à jour: 03/05/2013

Presentation - Objectives and problem statement (Janina Karres)

English (EN) (89.77 Ko - PDF)

Première publication: 03/05/2013 Dernière mise à jour: 03/05/2013

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

English (EN) (1.27 Mo - PDF)

Première publication: 03/05/2013 Dernière mise à jour: 03/05/2013

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

English (EN) (256.28 Ko - PDF)

Première publication: 03/05/2013 Dernière mise à jour: 03/05/2013

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

English (EN) (104.77 Ko - PDF)

Première publication: 03/05/2013 Dernière mise à jour: 03/05/2013

Presentation - Study recruitment issues (Phillip Ambery)

English (EN) (743.04 Ko - PDF)

Première publication: 03/05/2013 Dernière mise à jour: 03/05/2013

Presentation - Questionnaire overview (Janina Karres)

English (EN) (129.85 Ko - PDF)

Première publication: 03/05/2013 Dernière mise à jour: 03/05/2013

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

English (EN) (485.91 Ko - PDF)

Première publication: 03/05/2013 Dernière mise à jour: 03/05/2013

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

English (EN) (84.43 Ko - PDF)

Première publication: 03/05/2013 Dernière mise à jour: 03/05/2013

Presentation - Meta-analysis

English (EN) (100.85 Ko - PDF)

Première publication: 03/05/2013 Dernière mise à jour: 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 Ko - PDF)

Première publication: 03/05/2013 Dernière mise à jour: 03/05/2013

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

English (EN) (338.21 Ko - PDF)

Première publication: 03/05/2013 Dernière mise à jour: 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 Ko - PDF)

Première publication: 29/01/2013 Dernière mise à jour: 29/01/2013