Sandrine DE SOUSA

Senior Advisor Compliance & Quality
of External Communications

Sandrine has a rich and varied experience in various fields related to her professional background. Indeed, after starting her career in the field of statistical market research at Taylor Nelson Sofres, she continued her journey as a hospital representative for Genévrier and Lundbeck laboratories, where she notably developed expertise in quality by implementing a framework for the care of Alzheimer’s patients in residential care homes.

Building on this initial experience in quality, she subsequently obtained several certifications, including the IRCA ISO 9001, and founded her own consulting and auditing company.

As the founder and president of Medexx Consulting, Sandrine supported numerous laboratories and service providers in establishing quality systems and audits on the charter for promotional information. She is also a COFRAC-accredited auditor for the certification of promotional information, a skill she has developed over the years by auditing more than 40 laboratories per year.

In 2019, Sandrine took on the leadership of the quality and regulatory department of a promotional information provider. In this role, she managed the department, implemented and monitored the quality management system, and organized numerous audits for Pharmafield’s partners. She also oversaw certification audits and coordinated the updates of procedures and quality documents with her teams.

She also participated in the working group in close collaboration with the HAS (French National Authority for Health) to develop the reference framework for the promotional information charter on medical devices.

At ATESSIA, Sandrine will continue to leverage her expertise in compliance and quality of external communications, covering a wide range of topics such as compliance with promotional and non-promotional activities, regulatory training, and managing audits for laboratories and service providers. She will also address the obligations of the exploiter in terms of external communication, ensuring compliance of practices with regulatory requirements and assisting teams in implementing effective systems. Her ability to lead complex projects, structure quality systems, and meet regulatory requirements, particularly regarding the French Anti-Gift Law and the promotional information charter, will be a real asset for the team and our clients.

Expertise

Exploitant

Compliance

Audits

Training

Medicine & Medical device

Promotional information charters

Advertising

French Anti-Gift Law / Transparency of links