Marie Coulon, PharmD

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Provepharm SAS
Regulatory Affairs Project Manager
Marie Coulon, PharmD, is a Regulatory Affairs Project Manager at Provepharm SAS, a molecule vitalization company in Marseille, France. After the completion of her pharmaceutical studies and a masters degree in European regulation of healthcare products, she worked for five years as European Project Manager at ANSM, the French authority for medicines and other health products. She then joined Provepharm SAS to work on the regulatory side of medicines and medical devices already marketed or currently developed by the company. Her position provides a wide view of European medicines and medical devices regulations (notably the new Medical Devices Regulation (MDR) establishing UDI). She joined the ISPE France Affiliate’s Unique Device Identification (UDI) Medical Device Work Group in 2019, which aims to produce tools to help project stakeholders with UDI.

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Medical Device UDI Components Management in the European Union
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Medical Device UDI Components Management in the European Union

Since 2019, the ISPE France Affiliate’s Unique Device Identification (UDI) Medical Device Work Group has been producing tools to help project stakeholders within the EU or overseas understand and comply with EU regulations of UDIs in medical devices. Some of those tools are highlighted in the article.