November 7, 2024 - Webinar - Regulation of healthcare products: from the laboratory to the patient's bedside
Discover more about the third webinar in the BIOQuébec Intellectual Property Webinar Series offered by Fasken, taking place on November 7 from 8 a.m. to 9 a.m., titled: "Regulation of healthcare products: from the laboratory to the patient's bedside."
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Regulation of healthcare products: from the laboratory to the patient's bedside
Whether it's pharmaceutical products, medical devices, or others, health products are heavily regulated throughout their lifecycle. Clinical trials, market authorizations, advertising, and the excessive pricing of patented drugs are primarily regulated at the federal level, while provinces have jurisdiction over drug insurance and health professions. This presentation will provide an overview of the Canadian regulatory landscape, focusing on the key steps in the commercialization process.
OUR SPEAKERS
Dara Jospé – Partner
Dara Jospé practices in the areas of life sciences, health, and food regulation. She advises manufacturers on all stages of the pharmaceutical product lifecycle, from product design to consumer sales. In all cases, Dara finds creative, cost-effective ways to help manufacturers comply with legal prohibitions and policies, while keeping their commercial interests and patient safety in mind.
She regularly assists companies with regulatory liability and compliance matters. She advises them on the launch of new health products in Canada, reviews their advertising materials, develops patient support programs for healthcare professionals, provides guidance on anti-corruption concerns, and drafts standard operating procedures.
Geneviève Shemie – Lawyer
Geneviève is an experienced life sciences lawyer. She practices in health and food regulation in the intellectual property group at Fasken's Montreal office. She advises manufacturers at all stages of the pharmaceutical product lifecycle, from design to consumer sales. She also advises clients on the development and protection of intellectual property strategies.
Geneviève has experience in regulatory liability and compliance for life sciences companies, including advice on the launch of new health products in Canada, recommendations in Health Canada investigations and recalls, advertising material review, and the development of patient support programs.
She also provides advice on drug and medical device pricing and reimbursement issues. Geneviève also offers strategic advice to companies of all sizes for managing their intellectual property assets, including brand, patent, and copyright protection.