Denisa Chesoi

Background

About Denisa Chesoi

More than 15 years experience as a clinical reviewer in the scientific and regulatory pre-market evaluation of safety and efficacy of biological products. Knowledge of post-market surveillance regarding risk management and signal detection. Extensive clinical and regulatory knowledge relevant to design and conduct of clinical trials for Phase 1-3 in various therapeutic areas (e.g. oncology, autoimmune diseases, hematology) and with specific product lines (e.g. monoclonal antibodies, blood products, vaccines). Experience reviewing First in Human Clinical Trial Applications (CTA), First Entry CTA and Phase 3 pivotal studies. Experience participating in pre-submission and review meetings, providing advice and recommendations to stakeholders and management. Strong knowledge of the Food and Drug Act, Canadian and international regulations (e.g. FDA, EMA) and International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). Knowledge of clinical practices in family medicine. Master in Drug Development. Strong interpersonal relations, teamwork, communication, leadership, values and ethics Fluent in English, French.