Calls for civil society members for two EMA committees

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29/07/2015

Calls for civil society members for two EMA committees

Expressions of interest to represent civil society at PRAC and CAT to be submitted to European Commission by 30 September 2015

The Health and Food Safety Directorate-General of the European Commission has launched calls for expressions of interest to represent civil society in two scientific committees of the European Medicines Agency (EMA): the Pharmacovigilance Risk Assessment Committee (PRAC) and the Committee for Advanced Therapies (CAT).

The PRAC has one member and one alternate representing patients’ organisations as well as one member and one alternate representing healthcare professionals’ organisations. The term of office of the current members expires on 29 February 2016. The new civil society members will be appointed for a three-year period.

The CAT has two members and two alternates representing patients’ organisations and two members and two alternates representing clinicians, and the term of office of the current members expires on 30 June 2016. The new members will be appointed for a renewable period of three years.

For both calls, expressions of interest should be submitted to the European Commission no later than 30 September 2015, either by email or post. Further information on the assessment criteria and the application process can be found on the Commission’s website.

The role of patients’ organisation representatives in the CAT and PRAC is to ensure that patients’ needs and views are taken into account in all the discussions of the committees.

Healthcare-professional organisation and clinician representatives are responsible for ensuring that the needs of practitioners, clinicians, pharmacists or other health professionals, as well as real-life implications of any committee recommendations, are also considered during the discussions of the committees.

Appointees will be involved in the committees’ work in the same way as other committee members. They are expected to attend the monthly committee meetings at EMA and to actively contribute to scientific discussions, examine documents and make comments with a specific focus on the group that they represent.

The European Commission will appoint the civil society members after consultation with the European Parliament.

About EMA committees

PRAC has an important role in overseeing the safety of medicines in the European Union. The committee’s activities cover all aspects of the safety monitoring and risk management of medicines.

CAT is responsible for assessing the quality, safety and efficacy of advanced-therapy medicinal products (ATMPs) and following scientific developments in the field. ATMPs are medicines that are derived from gene therapy, cell therapy or tissue engineering.

PRAC and CAT have one member and alternate per Member State and the PRAC also has six scientific experts appointed by the European Commission. In addition, these committees have representatives of healthcare-professional and patient organisations as members, as foreseen by the European pharmaceutical legislation (Regulation (EU) No 1235/2010 and Regulation (EC) No 1394/2007 on advanced therapy medicinal products). This is also the case for two other scientific committees of the Agency, the Paediatric Committee (PDCO) and the Committee for Orphan Medicinal Products (COMP).

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