Barbara Marcondes Abissi

Holds a degree in Biochemical Pharmacy from the Universidade Estadual Paulista Júlio de Mesquita Filho (2015).Professional with over 10 years of experience in CROs, including international and multicenter studies, acting as a specialist with extensive knowledge of Brazilian resolutions related to clinical trials. Experience in Phase I/II-IV studies, including drugs (adult and pediatric), radiopharmaceuticals, and rare diseases, gene therapy, and advanced therapies. Skilled in preparing and reviewing dossiers for submission to ANVISA, CEPs, and CONEP. Experience with submissions to CIBio/CTNBio and import/export processes for investigational products, GMOs, and clinical supplies. Responsible for overseeing regulatory and start-up operations in Brazil, including team management, quality control, and deliverables. Knowledge of GMO resolutions in various countries and training in EU-CTR Regulation. (Source: Lattes Curriculum)