Читать книгу Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) - William Gregory - Страница 119

A matrix organization has been set up over the past several years as follows:

Seven Products Departments: These are accountable for the activities and missions for dedicated products (registration dossier review, pertinence of safety surveillance measures and benefit–risk assessment, scientific and medical products information).

Five Business Departments: Regulatory & Legal, Approval, Surveillance, Inspection, Controls).

Four Resources Departments: HR, Administration & Finances, Information Systems, Flows Mastering & Electronic Document Management.

The surveillance department handles pre-registration and post-marketing surveillance with the following missions:

Monitor signals/alerts with the support of regional and local surveillance systems/organizations;

Ensure organization and coordination of regional and local vigilance structures;

Monitor signals/alerts assessment and risk management;

Develop epidemiology;

Enlist internal and external experts to support the other departments in their decision-making process in the PV field;

Maintain approval and control of advertising;

Handle a secured process for medicines supply;

Assesses the drug’s market with a medico-economic viewpoint in a public healthcare perspective;

Represent the ANSM at both European and international level for safety-related topics (PRAC, CHMP, CMDh, CIOMS, ICH, etc).

To support the ANSM Surveillance department, 31 regional PV centres are collecting ICSRs from hospital records or case reports provided by GPs and other specialized healthcare professionals or patients. Based within a hospital and university desk, they are collecting case reports, informing healthcare professionals on the drug safety profile and prescription rules. In addition, at the request of the ANSM Surveillance department, they are involved in the safety signal detection and assessment process, in benefit–risk assessment dossier, in labeling update assessment, in PSURs/PBRERs review and assessment; depending on their specialty/center of interest, they also are part of various working groups (drug–drug interaction, pregnancy, safety database, etc.).