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The EC is calling for interested parties for their safety and orphan drug committees.
On Nov. 3, 2023, the European Commission announced it was launching a selection procedure for experts looking to join the European Medicines Agency’s (EMA’s) independent Pharmacovigilance Risk Assessment Committee (PRAC) and Committee for Orphan Medicinal Products (COMP). PRAC is looking for six appointees, and COMP is looking for three new members.
The six PRAC experts will be appointed to a three-year term that starts on July 2, 2024 and will have an active role in supervision of medicines in Europe. Members of PRAC are independent scientific experts and are expected to actively contribute to PRAC discussions.
COMP is looking for three new committee members to represent patients’ organizations for a three-year term that begins July 1, 2024. Members participate in COMP procedures and attend monthly meetings. They also contribute to scientific discussions, examine documents, and speak for their target group. COMP members are also members of EMA’s Pharmacovigilance Risk Assessment Committee, Paediatric Committee, and Committee for Advanced Therapies.
“The COMP has a strong tradition of involving patient representatives in its work. Its main task is to examine applications sent by companies and decide whether their medicines can be designated as 'orphan'. An orphan medicine is used in the diagnosis, prevention, or treatment of a life-threatening or chronically debilitating condition that is rare, which means it affects no more than five in 10,000 people in the European Union (EU). The role of a patient organization representative in the COMP is to give a voice to patients and ensure their needs are taken into account in the Committee's decision-making process. Although a medical background is not required, candidates may benefit from a sound knowledge of medical and, to a certain extent, regulatory issues related to medicines in the EU,” the agency stated in a press release.
Submissions for applications for either commission are due Dec. 7, 2023 at 12:00 CET. Current members may also re-apply.