The Health and Food Safety Directorate-General of the European Commission has launched a call for expressions of interest to represent civil society in the European Medicines Agency’s (EMA) Paediatric Committee (PDCO).
The PDCO has three members and three alternates representing patients’ organisations as well as three members and three alternates representing healthcare professionals’ organisations. The terms of office of the current members expires on 31 July 2017. The new civil society members will be appointed for a three-year period.
Expressions of interest should be submitted to the European Commission by 31 October 2016, either by email or post. Further information on the assessment criteria and the application procedure can be found on the Commission’s website.
The role of patient organisation representatives in the PDCO is to ensure that the views and needs of children (and their parents) are taken into account during the decision-making process of the Committee. Healthcare professional organisation representatives are responsible for ensuring that the needs of practitioners, clinicians, pharmacists and other healthcare professionals are also considered when the Committee assesses proposals for clinical trials in children.
Representatives of patient and healthcare professional organisations are involved in PDCO procedures in the same way as other Committee members. They are expected to attend monthly Committee meetings at the Agency and to actively contribute to scientific discussions, examine documents and make comments with a specific focus on the target group they represent.
The European Commission will appoint the civil society members after consultation with the European Parliament.
The main role of the PDCO is to assess and adopt an opinion on the content ofpaediatric investigation plans, which are submitted by medicine developers and describe how a medicine under development will be tested in children. This includes assessing applications for full or partial waivers and applications for deferrals.
Like the Agency’s other committees, the PDCO has one member per Member State. In addition, the European Paediatric Regulation foresees the participation of civil society representatives.
Similarly, the member lists of the EMA’s Pharmacovigilance Risk Assessment Committee, Committee for Orphan Medicinal Products and Committee for Advanced Therapies also include representatives of healthcare professional and patient organisations.