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Virtual

Nov 02, 2023 9:00 AM - Nov 02, 2023 12:30 PM

Global Advertising and Promotion – Considerations for Compliance and Success

This is a Pre-Conference Short Course in conjunction with the Canada Annual Meeting.

Instructors

Amber  McLeod, PhD

Amber McLeod, PhD

Immunology, Virology, and Specialty Head, Regulatory Affairs, Abbvie Corporation, Canada

Amber McLeod has held the role of Lead, Regulatory Affairs at AbbVie Canada since May 1, 2020. She leads a team of Regulatory Affairs professionals focused primarily on the filing and approval with Health Canada of biopharmaceutical drug submissions for clinical development and commercial products in the areas of Immunology, Oncology, Virology, Neuroscience, Hormone Replacement Therapy, and Specialty Care. Amber joined Abbott in January 1999. Over her 24-year career with Abbott/AbbVie, she held various roles of increasing responsibility where she led and managed countless regulatory filings, approvals and product launches in different therapeutic areas. Amber holds a Doctorate in Pharmacology and Therapeutics from McGill University.

Marcia  Sam

Marcia Sam

Regulatory Affairs Strategy and Policy Manager, Hoffmann-La Roche Canada Limited, Canada

Marcia Sam is enjoying her role as a Regulatory Affairs Strategy and Policy Manager at Roche Canada. 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

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

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

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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