Sophie Lucas-Samuel, France

Head of Safety and Quality Department
Medical and Scientific Directorate
Agence de la biomédecine

Head of the Quality and Safety Department at the Biomedecine Agency (France) The Department is responsible for the coordination of the national vigilance system of Assisted reproductive medicine and of the national vigilance system of Organs, Tissues, Cells and breast milk for therapeutic purposes. It is also responsible for the development of quality assurance system in the hospital sites in charge of collection and graft of organs, tissues and cells. Previously, Head of the Advanced Therapy Medicinal Products, Organs, Tissues and Cells Preparations Department, at the French National Agency of Medecine and Health Products Safety (ANSM) The department was responsible for the assessment of various procedures at national and at European level: Marketing Authorization Applications, Clinical trials, scientific advices. The assessments included the quality, efficacy, safety and vigilance aspects. It was implicated in the drafting of the regulations at national and at European levels.



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