Instructors
Amber McLeod, PhD
Immunology, Virology, and Specialty Head, Regulatory Affairs, Abbvie Corporation, Canada
Amber McLeod has held the role of Head of Immunology, Virology, and Specialty at AbbVie since May 2020. In this role, she leads a team of Regulatory Affairs professionals focused on filing and obtaining approval for biopharmaceutical drug submissions with Health Canada, spanning clinical development and commercial products in the fields of Immunology, Virology, Neuroscience, and Specialty Care. Amber joined Abbott in January 1999. Over her 25-year tenure with Abbott/AbbVie, she has held various roles of increasing responsibility, leading and managing numerous regulatory filings, approvals, and product launches across diverse therapeutic areas. Amber holds a Doctorate in Pharmacology and Therapeutics from McGill University.
Marcia Sam
Senior Manager, Regulatory Affairs, Regeneron Canada Company, Canada
Marcia Sam is a Senior Manager, Regulatory Affairs at Regeneron Canada Company. With over 16 years of experience in the Biotech/Pharmaceutical industry, she has a diverse range of experiences with exposure to different areas of drug development, regulatory submissions in therapeutic areas as Hematology, Neuroscience, Oncology, Virology, Rare Diseases, etc., volunteered on the regulatory affairs committees of IMC, was a past guest speaker and instructor for regulatory courses at Seneca College of Applied Arts and Technology. She holds a BSc (Honours) degree in Neuroscience/Biology from the University of Toronto and a Post-graduate diploma in Pharmaceutical Regulatory Affairs and Quality Operations from Seneca College.
John K. Wong, MPharm, RPh
Consultant, ADWORX REG INC., Canada
John Wong is a pharmacist graduate from Université Laval, Quebec, Canada. He started his career at the Toronto General as an Oncology Pharmacist. In 1998, he joined the Pharmaceutical Advertising Advisory Board (PAAB), a national regulatory body for the review of drug advertising, and later became the Deputy Commissioner. After 10 years at PAAB, John decided to cross over to the ‘other side' and landed at Ogilvy CommonHealth as an Account Director where he helped launch specialty products in Oncology, Hematology and HIV. John was recently the Director, Regulatory Drug Advertising & Promotion at TPIreg/ Innomar Strategies, providing consultation and review services for drug and medical device advertising.
Carla Che
Director, Regulatory Affairs, Gilead Sciences Canada, Inc., Canada
Carla is a Director of Regulatory Affairs at Gilead Sciences Canada, Inc. Carla’s experience includes leading and developing regulatory strategies for NDSs (pharmaceutical drugs), labeling, and drug advertising & promotion. She is passionate about project management and process improvements.
Genevieve Michaux, LLM
Partner, Life Sciences, King & Spalding International LLP, Belgium
Genevieve is a Belgian and French qualified lawyer who focuses on European and national food and drug law, with particular emphasis on issues surrounding the regulation of drugs, biologics, medical devices, cosmetics and food both at the EU and national levels. Her work covers a wide range of issues, including regulatory status of borderline products, life cycle management, CT and investigations, labeling and promotions for all categories of products, and issues raised by specific categories of medicinal products, such as pediatric, orphan or advance therapy medicinal products. She has a broad litigation experience in life science matters, including product liability, advertising and promotional activities, and generic approvals.
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