The CTV sets its agenda or program BGB324 ic50 of work based on suggestions from various sources, including the DGS and pharmaceutical companies. The DGS refers any problems to the CTV that it identifies as being concerned with public health and vaccination. The companies inform the CTV when they are awarded marketing approval for a new vaccine or in the event of modification of a previous registration. The CTV can also decide to independently propose recommendations on issues that it thinks need consideration.

However, this must be validated by an HCSP committee. To be considered for validation, a document must define the procedures and responsibilities for the working group (nomination of the chairman, membership make-up, functioning, production, and publication of guidelines),

while another document outlines the procedures to be undertaken when a referral is received by the CTV, as well as an estimated timeline of expected deliverables. Pharmaceutical companies may have a say in setting the agenda. As soon as a vaccine has obtained market authorization (MA), the owner of the MA can submit a dossier to the CTV in order to initiate the process of establishing guidelines on vaccine use. Granting the MA and establishing guidelines are separate procedures with different endpoints. The MA is granted by the AFSSAPS following an assessment of the efficacy and safety of the vaccine. Currently, registration procedures are European-based. selleck inhibitor Any possible guidelines for vaccine use are established after the MA is obtained, with the main criterion being the impact of the new product on public health. This type of procedure is not limited to new products; it may also be applied when new data on an existing vaccine show a change in its impact, thus affecting guidelines on its use. Sources of technical data and expertise available to the committee include official CTV members, national centres of expertise, invited ad hoc experts from within the country, WHO position statements, and working groups. A referral made to the CTV concerning a particular topic usually leads to the creation of a dedicated working

group that is responsible for investigating the topic. Separate working groups TCL are established to look at specific issues. The groups are a priori ad hoc but can be reactivated on as-needed basis (e.g., when reconsidering a recommendation based on new data). Certain groups (such as those concerned with meningococcus and influenza) are, in fact, permanent working groups due to their topical nature. There are no terms of reference for working groups. When a referral is received, the CTV Chairman establishes a working group and proposes a working group chairman. The CTV Chairman then sends the chairman of the working group a lettre de mission or mission statement, which defines the fields of expertise needed, provides details on the delivery of the report, and may also propose a work plan.