Paediatric Committee (PDCO)

The main responsibility of the Paediatric Committee (PDCO) is to assess the content of paediatric investigation plans and adopt opinions on them in accordance with the Pediatric Regulation (Regulation (EC) 1901/2006). This includes the assessment of applications for a full or partial waiver and assessment of applications for deferrals. The committee began in January 2007

  • A Paediatric Investigation Plan (PIP) sets out a programme for the development of a medicine in the paediatric population. The PIP aims to generate the necessary quality, safety and efficacy data through studies to support the authorisation of the medicine for use in children of all ages. The plan is submitted by a pharmaceutical company to the PDCO, which reviews it and publishes an opinion with its decision.
  • A compliance check is performed to verify that all the measures agreed in a PIP have been conducted in accordance with the decision, including the agreed timelines. Full compliance with all studies/measured contained in the PIP is one of several prerequisites for obtaining the rewards and incentives provided for in Articles 36 to 38 of the Paediatric Regulation.
  • Waivers can be issued if there is evidence that the medicine concerned is likely to be ineffective or unsafe in the paediatric population, or that the disease or condition targeted occurs only in adult populations, or that the medicine, or the performance of trials, does not represent a significant therapeutic benefit over existing treatments for paediatric patients.

 

Another role of the PDCO is contributing to the development of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA), a network of research networks, investigators and centres with recognised expertise in performing clinical studies in children.

 

 

 

 

See PDCO members for the full list of current members.

Composition of Committee

  • 22 members from National Competent Authorities
  • 5 members from Committee for Human Medicinal Products (CHMP) + alternates
  • 2 Health Care Professionals + alternates
  • 2 Patients’ representatives + alternates
  • 2 non-voting members (Iceland and Norway)

 

Tsveta SchynsTsveta Schyns is a EURORDIS nominated Patient Representative

Current mandate: 2014 – 2017
Alternating Hemiplegia Network

 

 

 

 

Kerry Leeson-Beevers Kerry Leeson-Beevers is a EURORDIS nominated Patient Representative

Current mandate: 2014 – 2017
Alstrom Syndrome UK

 

 

 

 

Dirk MentzerDirk Mentzer is Chair of the PDCO

Current mandate: 2013 – 2016
Paul-Ehrlich-Institut, Germany

 

 

 

 

 

Page created: 05/02/2010
Page last updated: 23/11/2016
 
 
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