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Pharmacovigilance - Policy

The Pharmacovigilance Department is in charge of monitoring all pharmaceutical products, from the first time a compound is administered to human subjects (phase I clinical trials) to the end of the product's life cycle.  

A global and local organization

To ensure the safe use of products under development and those that are already on the market, sanofi-aventis has instituted:

  • centralized pharmacovigilance divisions (one for vaccines and one for all other products), each of which collects all information reported worldwide, whether during clinical trials or through unsolicited notification;
  • local pharmacovigilance divisions in each of our subsidiaries, whether or not there are regulatory pharmacovigilance obligations (i.e., concerning the reporting of adverse events) in these countries.

These local structures collect, record, analyze and communicate information reported by patients, clinical trial investigators and healthcare professionals. In addition, these pharmacovigilance groups interface with local health authorities and various departments within the subsidiary.

Progress and Goals
Areas for ProgressGoals
Improve the sanofi-aventis pharmacovigilance data management process.Develop a new computerized pharmacovigilance system.
 

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  1. © sanofi-aventis 2007-2008
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  3. | Update : September 10, 2008