Mariaelena Caboni is a Principal Scientist at Holobiome. Mariaelena has over four years of experience in Regulatory Affairs and has coordinated and prepared CMC submission packages for international dossiers, including eCTD format. Mariaelena has also supported Biologics License Application submissions and prepared communication documents to Health Authorities, such as FDA and EMA. In addition, Mariaelena has experience in coordinating and reviewing Quality documentation and supporting GMP inspections, renewals, and compliance activities.
Mariaelena Caboni has a Bachelor's degree in Biotechnology from Università di Pavia, a Master's degree in Biotechnology from Alma Mater Studiorum – Università di Bologna, and a Doctor of Philosophy (PhD) in Industrial and Molecular Biotechnology from Università degli Studi di Napoli Federico II. Mariaelena also has a Corso di Master Universitario di 2° livello-CMU2 in Pharmaceutical Technologies and Regulatory Affairs from Università degli Studi di Perugia. Mariaelena Caboni is certified by The Johns Hopkins University in Evidence-based Toxicology, by University of Delaware Professional and Continuing Studies in Clinical Trials Management Certificate, by University of Perugia in Regulatory Affairs, and by American Safety & Health Institute in CPR and AED (Adults).
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