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Patient safety

Patient safety is the primary focus of our quality, pharmacovigilance and counterfeit teams.

Our approach involves guaranteeing the quality of each phase of the product’s life cycle, from the earliest steps of development to the distribution of products to sales channels in compliance with regulatory requirements worldwide.

 

Quality systems

Sanofi’s quality approach is designed to ensure that we provide safe and effective products that are developed, manufactured, distributed and marketed in compliance with regulatory requirements and internal company standards worldwide.

Our quality systems are under the responsibility of the Global Chief Quality Officer, who has direct access to the CEO.

 

Pharmacovigilance: monitoring product safety

Our pharmacovigilance teams monitor safety and are able to adjust the benefit-risk profile of our products: prescription medicines, vaccines, consumer health products, generics, medical devices and animal health products. Pharmacovigilance helps determine the best conditions of use for treatments, and provides physicians, healthcare professionals and patients with comprehensive, up-to-date safety information, including potential risks associated with a product.

 

Fighting against counterfeit drugs

According to the U.S. FDA, counterfeit drugs account for more than 10% of the global medicines market. It is estimated that up to 25% of the medicines consumed in developing countries are counterfeit or substandard.

Safeguarding the integrity and traceability of our products and being a solid partner in the global fight against counterfeit medicines are essential for patient safety, and Sanofi has adopted a comprehensive approach:

  • we have run our own dedicated anti-counterfeit laboratory
  • we also actively support initiatives by public authorities:
    • working closely with local authorities and professional organizations to educate the public and raise awareness about this growing phenomenon
    • cooperating with law enforcement, customs officials, health authorities and other pharmaceutical companies in efforts to seize potentially harmful products and shut down clandestine production facilities and illegal websites that sell counterfeit
    • acting to protect the security of the supply chain and developing innovative, high-tech solutions to safeguard the integrity of our product and to prevent falsification

For more information:  CSR report 2015

 
 

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