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Pharmacovigilance - Actions

 

Centralized pharmacovigilance management

Centralized management for product pharmacovigilance and product safety information

To ensure patients are better protected and improved information is available to all, sanofi-aventis manages an international pharmacovigilance network from a central structure that is in constant contact with clinical development structures. A new computerized system to centralize pharmacovigilance data is being developed to enhance the quality and speed of data management. These data are shared with Regulatory Affairs, which informs the health authorities, and with the clinical teams who inform investigators, ethics committees and patients through the Clinical Research Units. 

This approach also makes it possible to adapt the trial methods, in particular by having Data Monitoring Committees process this information for studies where patients are especially vulnerable in light of their disease.

Currently, 82 information-gathering sites have been established worldwide, including 28 working in liaison with the Clinical Research Units.