Hugo Hamel

Hugo Hamel graduated from the University of Montreal with a B.Sc. in Biochemistry, a M.Sc. in Molecular Biology and a M.Sc. in Pharmaceutical Sciences. He also graduated with a MBA in 2015. Mr. Hamel spent his last 24 years working with the Biologic and Radiopharmaceutical Drugs Directorate (BRDD) at Health Canada as Senior Evaluator with the Monoclonal Antibodies Division and Division Manager of the Radiopharmaceuticals and Monoclonal Antibodies (Inflammation) Division. He is currently Associate Director with the Center for Blood, Blood Products and Biotherapeutics at BRDD. During his career with BRDD, Mr. Hamel was involved with reviewing the Chemistry, Manufacturing and Controls information pertaining to Clinical Trial Applications (CTAs), New Drug Submissions (NDSs) and Post-Marketing changes associated with Biotherapeutics. He also acted from 2005-2025 as the BRDD lead of the working group in charge of developing and updating the Canadian Post-NOC changes quality guidance and represented Health Canada on the WHO drafting group in charge of developing the WHO Guidelines on procedures and data requirements for changes to approved biotherapeutic products. He was a member of the ICH Q12 IWG and leads its implementation in Canada. Mr. Hamel is also the regulatory chair of the ICH M4Q(R2) EWG and led the implementation of the CTD guidance document for biotherapeutic and blood products at Health Canada. He is pleased to provide an overview of the ICH M4Q(R2) guidelines recently released for public consultation.