Workpackages

WP 3

WP3 studies the framework conditions for research in children as this field is restricted by several rules and regulations and raises several ethical issues:
To provide an overview of existing regulatory, ethical, social framework conditions for research in medicines for children and opportunities for collaboration.

Workpackages team
Workpackage leader: Italy, Istituto Superiore di Sanita
dr. Anne-Laure Knellwolf

Work package team members
Estonia, ESF

Deliverables
D 3.1 Analysis of existing regulatory and ethical framework relevant for medicines for children research. As an outcome of T3.1, this state of the art report on the regulatory and ethical framework conditions will be further used to identify T3.3 and D3.3 and D3.4.

Annex 1 by Stéphane Bauzon, PhD, Expert in Philosophy of Law and Bioethics, University of Tor Vergata, Rome. Italy (final version 27 February 2009)

Annex 2 by Ornella Della Casa Alberghi, MD PhD Clinical Pharmacologist, Scientific Direction, G. Gaslini Institute,Genoa, Italy (final version 13 March 2009)

D 3.2 Overview of social perceptions and attitude regarding medicines for children research

D 3.3 Identification of regulatory, ethical, social opportunities and barriers affecting medicines for children research

D 3.4 Recommendations of framework conditions facilitating medicines for children research

Publications:
Abstract and Oral presentation at the 6th European Congress on Tropical Medicine and International Health and of the 1st Mediterranean Conference on Migration and Travel Health, Verona September 6-10, 2009

Oral Presentation at Marseille 20 June 2008 on legal and ethical perspectives on informed consent.

Poster presentation at ESDP Congress Rotterdam 6 June 2008

Oral presentation at TRIPR Congress Genoa 30 May 2008

Framework conditions facilitating paediatric clinical research