Liikmete nimetamine

Saatja: <[email protected]> Saadetud: 21.09.2022 09:27 Adressaat: <[email protected]> Teema: Invitation to nominate new Vigilance Expert Subgroup (VES) members Dear National Competent Authorities for Blood, Tissues and Cells and Organs, The Vigilance Expert Subgroup (VES) would welcome new nominations of NCA or of vigilance experts with whom you work, to contribute to the work of the VES. All sectors are needed - blood (including blood donors); tissues and cells sectors of medically assisted reproduction, haematopoietic stem cells as well as tissues/cells; and organs. If a country is represented in the VES by more than one person, only one members expenses for attendance at a physical VES meeting will be reimbursed. The working subgroups of the VES are: Subgroup for SARE reporting improvement. Provides technical expertise in preparing the Blood and Tissues/Cells SARE reporting exercises and will be evaluating the need for further improvements following implementation of the reporting webforms for the 2022 exercise. Subgroup for RAB/RATC review, first convened in 2021. A need for updated user training materials has been highlighted. Subgroup for VES and Inspections Expert Subgroup (IES) collaboration and cross-fertilisation, first convened in 2021. Focused on providing support/input to IES work on guidance relating to inspection of vigilance arrangements and evaluating results of vigilance reporting Organs subgroup. As announced, a voluntary pilot EU data collection exercise (MS 2022 SARE data) will take place in early 2023, with a survey of all NCA with a view to strengthening MS level organs vigilance. Please nominate vigilance experts from your MS who will be able to actively contribute in the VES working subgroups. Deadline: if possible before 10th October in view of their participating in the (online) autumn VES meeting (date to be announced in the forthcoming weeks). In addition, it would be helpful if you can reconfirm experts who are already members of the VES and who wish to stay involved. Please provide the following details for each nominated expert: Country Surname Name Organization Email Thanking you for your support, The SoHO team. European Commission DG SANTE (Health and Food Safety) Unit B4 Medical Products: quality, safety, innovationOffice address: Rue Breydel 2, 06/004, B-1049 Brussels/Belgium