Belinda Yap joined Innomar Strategies as HEOR Manager in 2016, where she is responsible for the implementation of HEOR projects in the Innomar Consulting Services and Patient Support Programs. 

Prior to her role at Innomar, Belinda worked at the Programs for Assessment of Technology in Health (PATH), McMaster University.  At PATH, she designed and managed large multi-center clinical studies, and applied specialized knowledge and scientific principles in support of a variety of health technology assessment (HTA) projects for both public and private sectors, including reimbursement of new drugs in Canada.  She also has extensive experience developing and maintaining relationships with key thought leaders and healthcare providers. 

Belinda obtained her MPH in Healthcare Management (Columbia University), her Ph.D. in Health Sciences and Technology (Harvard Medical School and Massachusetts Institute of Technology), and completed her post-doctoral training at the Brigham and Women’s Hospital (Boston).  She has received funding and authored publications in various therapeutic areas, including depression, stroke, heart disease, diabetes, and cancer.

Belinda serves on the Board of Directors of the Canadian Association of Population Therapeutics (CAPT) organization, whose mission is to advance population-based research of therapeutic interventions, and is currently the leading venue for Canadian RWE conference and discussions.

Dr. Susan Lum is a Manager within the Bureau of Pharmaceutical Sciences, Therapeutic Products Directorate (now Pharmaceutical Products Directorate), Health Products and Food Branch, Health Canada.  She serves as a Health Canada Expert Working Group (EWG) member on the ICH Q13 regulatory guidance document for Continuous Manufacturing of Drug Substances and Drug Products. Dr. Lum, a Canadian-qualified pharmacist, earned her B.Sc.Phm., M.Sc. in polymers and controlled drug delivery and her Ph.D. in pharmaceutics at the University of Toronto.  Prior to joining Health Canada, she was employed within the pharmaceutical industry at a number of companies, including Patheon Inc. (now Thermo Fisher), providing technical and strategic oversight on new drug projects with challenging molecules and on new technologies and platforms.  Dr. Lum is the author or co-author of a number of peer-reviewed research papers, abstracts, a patent and a book chapter (Drugs and the Pharmaceutical Sciences series).  She served on the American Association of Pharmaceutical Scientist’s Pediatric Formulation Task Force.  Her international expertise was previously recognized with the Ebert Prize, co-sponsored by the Journal of Pharmaceutical Sciences and the American Pharmaceutical Association.

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 21 years working with the Biologic and Radiopharmaceutical Drugs Directorate (BRDD) at Health Canada as Senior Evaluator with the Monoclonal Antibodies Division and acting Division Manager of the Radiopharmaceuticals and Gene Therapies Unit. He is currently Division Manager of the Radiopharmaceuticals and Monoclonal Antibodies (Inflammation) Division.

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 2005-2021 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.

Mr. Hamel is also a member of the ICH Q12 IWG and leads its implementation in Canada.

He is pleased to provide an overview of the Health Canada’s Post-NOC changes Quality Guidance document.

Jackie Côté is a senior policy analyst at the Natural and Non-Prescription Health Product Directorate of Health Canada. She has been on the team for two years, leading a number of projects to implement the Self-Care Framework, including improving the labelling of natural health products.  

Mrs. Larissa Lefebvre is currently the Manager of the Submission Management Division within the Office of Clinical Trials, in the Therapeutic Products Directorate of Health Canada.  She started her career in the federal government in 2007 with the Patented Medicines Price Review Board, then working in the Healthy Environment and Consumer Safety Branch before moving to the Healthy Products and Food Branch where she held various regulatory positions related to pharmaceutical products. She holds a Bachelor degree with a Specialization in Biochemistry and a Major in French from the University of Western Ontario. 

Mary Speagle is a Senior Director Regulatory Affairs at TPIreg where she heads up a consulting team specializing in US and Canadian Regulatory Affairs.  Mary’s broad experience covering 20 years in regulatory consulting includes both prescription and OTC drugs (Pharmaceuticals, Biologics, Natural Health Products), Medical Devices and Cosmetics.  Mary has been working in the consulting area since 1998. Prior to joining TPIreg, she headed up a consulting team at Mapi Life Sciences (previously OptumInsight and CanReg Inc.). She is a prior contributing author to the RAPS Essentials of Healthcare Product Labeling and Fundamentals of Canadian Regulatory Affairs. Mary served for many years on the CAPRA Board of Directors and the RAPS Editorial Board. Mary is an active member of numerous industry associations.

Mohammed completed his Bachelor of Engineering, specializing in chemical engineering, at Laurentian University in April 2018. He then enrolled in the Pharmaceutical Regulatory Affairs and Quality Operations (RAQC) program at Seneca College, and later joined the Regulatory Project Management Division (RPMD) in TPD as a co-op student. Mohammed stayed on as a student in RPMD through the Federal Student Work Experience Program (FSWEP) until he returned to Seneca College to finish the RAQC program. After completing the program, Mohammed was bridged in as a Regulatory Project Manager (RPM) for the Bureau of Pharmaceutical Sciences (BPS) in July 2020, where he managed generic products/submissions. Mohammed has since then moved to the Bureau of Gastroenterology, Infection and Viral Diseases (BGIVD) as a RPM, where he now manages innovative Aids and Viral Diseases drugs.

Tracy Brown is the Project Manager for the XML PM Project. Tracy began her regulatory career at the Pest Management Regulatory Agency, where she worked as a scientific screening officer.  In 2005, Tracy moved to the Office of Regulatory Affairs within the Biologics and Radiopharmaceutical Drug Directorate. Her role as a Senior Regulatory Project Officer included participation in many projects, including leading roles in the revisions to guidance documents for preparing submissions in the CTD and eCTD formats. In 2018, Tracy moved to the Resource Management and Operations Directorate as a Project Manager where she has led several major projects, including the Medical Devices Post-Market System Renewal and the XML PM Project.