Working groups must include one or more regular voting members as well as one medical specialist from the PHAC (as Medical Lead). There are currently two Medical Leads (including the Executive Secretary) distributed among eighteen working groups. A PHAC Medical Lead is a physician PI3K Inhibitor Library concentration who works closely with the Working Group chair and NACI Secretariat to assist with the technical analysis, literature review, and drafting of Advisory Committee Statements in addition to other roles and responsibilities, such as

responding to medical inquiries to NACI. External content experts or other consultants may be invited to serve on a Working Group (e.g. representatives from the Canadian Immunization Committee or the Committee to Advise on Tropical Medicine and Travel) as necessary to provide broad input. Information on NACI’s structure and processes is contained within its Terms of Reference, available publicly on the PHAC website (http://www.phac-aspc.gc.ca/naci-ccni/tor-eng.php#12). These Terms of Reference may be amended at any GDC-0199 manufacturer meeting by consensus or by vote. The National Advisory Committee on Immunization has three face-to-face meetings a year which occur over 2 days. Ad hoc teleconferences of the full committee are held as needed, and email correspondence occurs regularly. Meetings are not open to

the public. Additional observers (e.g. health care students/post-graduate physician trainees or PHAC staff) may attend upon request and approval of the NACI

Executive Committee, and after agreeing to confidentiality requirements. Experts, including representatives from vaccine manufacturers, may be invited to make presentations as needed. For each meeting, detailed Minutes and a succinct Summary of Discussions are prepared by the Secretariat, reviewed by the Executive Secretary and Chair of NACI, and approved by the NACI. The Summary of Discussions is used for information sharing beyond NACI however the detailed Minutes is a confidential Tolmetin document that is not distributed beyond the Committee. The agenda for NACI meetings is created based on changes in the epidemiology of vaccine-preventable diseases, new products, or new evidence about existing products. Potential topics may be submitted by committee members and other stakeholders, and are accepted for addition to the agenda by the Executive Secretary, in consultation with the Chair. An executive committee (consisting of the Chair, Vice-Chair, Executive Secretary, PHAC Medical Leads and NACI Secretariat) meets regularly by teleconference between meetings to oversee the progress of the Working Groups, plan full NACI meetings and deal with inter-current issues that arise. Members, liaison representatives and consultants are required to submit annual conflict of interest declarations to the Executive Secretary, based on Conflict of Interest Guidelines.