Regulatory procedures for paediatric clinical trials and Pharmacovigilance

The aim of this WG is to support Partners in complying with regulatory requisites and focuses on the procedures to obtain CTs approval and authorisation and to comply with pharmacovigilance requirements during the conduction of clinical trials.

TEDDY started this activity in 2010 when a database containing information on the relevant local requirements and procedures to carry out the Clinical Trial Application in European and non-European Countries was developed. This database included the laws governing clinical trials, the ad hoc provisions for paediatric trials, the details on the ethics committees/national competent authorities, the procedures for compiling EU CTA form, and other relevant information related to clinical trials applications.

WG reference person:
Cristina Manfredi

Viviana Giannuzzi

Giulia Chiaruttini

Annalisa Landi

Laura Mangiarini

Kejla Musaraj

Bianca Tempesta

Valeria Pignataro

Federico Martinón Torres

Cristina Serén Trasorras