Luca Martinenghi
Non-clinical Expert - Toxicologist @Fresenius Medical Care
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WORK HISTORY
Non-clinical Expert - Toxicologist @Fresenius Medical Care
Responsible for creation and maintenance (SME) of non-clinical documentation for medicinal products (CTD module 2.4, 2.6 and 4)- Provide answer to questions raised in the context of marketing authorization applications, variation procedures and audits/inspections- Working closely with relevant stakeholders as member of cross-functional teams (labelling, pharmacoviglance, clinical and regulatory)- Internal point of contact for non-clinical topics (e.g. risk assessment of impurities, PDE derivation)- Define non-clinical strategy for medicinal products (development projects for new medicinal products)- Supporting projects in future markets/establishing new marketing authorization globally
EDUCATION
ITIS "G.Galilei" Crema
Perito industriale capotecnico in Tecnologia Alimentari
Università degli Studi di Milano
Safety assessment of xenobiotic and biotechnological products, Scienze del Farmaco - Master's Degree
Università degli Studi di Milano
Chemical safety and Toxicological Environmental Sciences (L-29), Scienze del Farmaco - Bachelor's Degree
ABOUT LUCA MARTINENGHI
Certified European Registered Toxicologist (ERT)
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