Mr. Hugo Hamel MSc, MBA

Mr. Hamel spent his last 20 years working with the Biologic and Radiopharmaceutical Drugs Directorate (BRDD) at Health Canada, where he is currently Division Manager of the Biotherapeutic Quality Division. During his career with BRDD, Mr. Hamel was involved with reviewing the CMC information pertaining to CTAs, NDSs and Post-Marketing changes associated with Biotherapeutics 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. Mr. Hamel is also a member of the ICH Q12 Implementation WG and leads its implementation in Canada. He is pleased to provide an update on the implementation status of this important guidelines in Canada.