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"is defined as the science and activities relating to the detection, assessment, understanding, prevention, and communication of adverse events following immunization, or of any other vaccine-or immunization-related issues."
"An adverse event (AE) is any untoward medical occurrence in a patient administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (for example, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product."
ICH E2D step 5 November 2003
Sanofi Pasteur has established a Global Pharmacovigilance organization working in accordance with various Standard Operating Procedures (SOPs) and is connected to a network of pharmacovigilance officers in the various countries where Sanofi Pasteur products are used in clinical trials or distributed and marketed.
Sanofi Pasteur is also informed of the local Pharmacovigilance organizations in these countries, and reports adverse events to local health authorities according to their local requirements.
For more information on pharmacovigilance:
International Conference of Harmonisation (ICH)
Council for International Organizations of Medical Sciences (CIOMS)
European Medicines Agency (EMEA)
Center for Diseases Control and Prevention (CDC)
Institute of Medicine (IOM)
World Health Organization (WHO)
US Food and Drug Administration (US FDA)
French Health Products Safety Agency (ANSM)
The Brighton Collaboration
European Federation of Pharmaceutical Industries and Associations (EFPIA)
Japan Ministry of Health Labour and Welfare
Government of Ontario (Canada)