Emline L.
Ivd Regulatory Assessor @ANSM Agence nationale de sécurité du médicament et des produits de santé
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WORK HISTORY
Ivd Regulatory Assessor @ANSM Agence nationale de sécurité du médicament et des produits de santé
Saint-Denis, FR
Surveillance of the market for IVDs throughout their life cycle (market surveillance control)- Assessment of the technical documentation and regulatory compliance of IVDs (instructions for use, labeling, etc.)- Participate in consultation procedures for companion diagnostic devices (CDx) to provide scientific opinions on the suitability of the CDx for the drug concerned- Participate in the development of European standards- Participate in the implementation of Regulation 2017/746 at national and European level by collaborating with the competent institutions.
EDUCATION
Université Grenoble Alpes
First year common to health studies, Medicine, pharmacy
Université Grenoble Alpes
Bachelor's degree, Biotechnology
Université Grenoble Alpes
First year of master’s degree (M1), Biotechnology
Université Grenoble Alpes
Second year of master’s degre (M2), Biotechnology
ABOUT EMLINE L.
As an experienced regulatory evaluator in MDIVs, I have acquired a global overview of…
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