Paediatric Committee – PDCO

Article type: Research Article

Authors: Rossi, Paolo | Scarselli, Alessia

Affiliations: PDCO Member (EMEA), Division of Immunology and Infectious Disease

Note: [] Corresponding author. E-mail: [email protected]

Abstract: The Paediatric Committee (PDCO) is a multidisciplinary setting composed by 5 CHMP members, 22 experts from the National Competent Authorities, 2 EEA, 3 patient/family's organisation representatives and 3 health professionals. The PDCO is accountable for providing opinion on PIPs, with deferrals/waivers and on compliance, and expert opinion on quality, safety and efficacy upon request by CHMP (marketing authorisations, scientific advice). In addition, PDCO is responsible for surveying paediatric needs, promoting networking, and monitoring Eudra CT.

Keywords: Paediatric committee, paediatric investigation plan, paediatric working party

DOI: 10.3233/PPL-2010-0276

Journal: Pharmaceuticals, Policy and Law, vol. 12, no. 1-2, pp. 93-95, 2010