Italian Medicines Agency Agenzia Italiana del Farmaco

Support and Coordination Secretariats and Advisory Committees

Support and Coordination Secretariats and Advisory Committees

The Italian Medicines Agency, with Resolution DG 1170/2019, has updated the Support and Coordination Secretariats and the Advisory Committees enhancing AIFA’s activity of scientific and regulatory evaluation, through the contribution of some of the top Italian experts in the main therapeutic areas for which new medicines are being registered.

These bodies, upon request, shall provide a valuable contribution to the activities of the Scientific Technical Committee (CTS) and the Price and Reimbursement Committee (CPR) and will make their professionalism available to the "core" of AIFA's activities.

The task of the Support and Coordination Secretariats, comprising a maximum of 13 members, chosen from AIFA staff (8 members) and external experts with proven scientific technical and health skills (for a maximum of 5), will be to guarantee support to the work of CTS and CPR by liaising with the Agency’s Offices and, if necessary, to request further information and opinions from the Advisory Committees.

As regards the Advisory Committees, their task is to carry out in-depth analyses and formulate opinions on regulatory and scientific issues of particular interest. The Committees are made up of a maximum of seven members, selected (in compliance with the Regulations on conflicts of interest approved by AIFA in March 2015) from among leading Italian clinical experts in the following therapeutic areas: Pediatrics, Oncology, Neurosciences, Endocrinology, Primary Care, Cardiovascular Area, Rheumatology, Internal Medicine (the latter two areas have recently been established).

With a view to saving costs and streamlining procedures, each Committee will meet electronically and only on particularly important occasions will the meetings take place at AIFA’s headquarters. The members of the Advisory Committees and Secretariats are not entitled to any compensation, except for members coming from outside Rome, who are entitled to reimbursement for mission expenses.

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