Latest Developments and Issues in Health Product Regulations
2900 - 550 Burrard Street
Kim Tyrrell-Knott, Member of the Firm, will copresent "Latest Developments and Issues in Health Product Regulations," a complimentary seminar hosted by Fasken Martineau.
Speakers will provide an overview of the latest developments and tendencies on drugs and medical devices regulations in US and Canada.
- Coverage of the hotly debated issues around how the regulatory framework should apply to digital health technologies
- Coverage of the new role of pharmaceutical companies in the digital health space
- An opportunity to hear key issues from Mathieu Gagné, author of Drug and Health Products Law in Canada, a reputable reference work in health law
- An opportunity to hear from San Diego based Kim Tyrrell-Knott who has extensive experience assisting new entrants to the FDA regulated environment, from mobile app developers to biotech innovators
Seminar attendees will have the opportunity to learn about:
- US regulatory landscape for Health IT and clinical decision support systems
- Recent FDA guidance for medical device manufacturers including medical device data systems, accessories and wellness products
- US policy developments impacting pharmaceutical manufacturers, including 21st Century Cures, market exclusivity changes and other protection against generic issues, as well as the accelerate approval pathway.
- Overview of the new powers granted to Health Canada under The Protecting Canadians from Unsafe Drugs Act (Vanessa's Law), which amends the Food and Drugs Act (power to require information; assessments; tests and studies; recalls; etc.). The Act applies to therapeutic products including prescription and over-the-counter drugs, vaccines, gene therapies, cells, tissues and organs, and medical devices.
- Information on the increased offences and punishments under the Food and Drug Act and related considerations for manufacturers
- Health Canada resources and some implications of submissions review
Mathieu Gagné, Partner, Fasken Martineau
Kim Tyrrell-Knott, Member of the Firm, Epstein Becker Green
7:30 am - 8:00 am | Registration and Continental Breakfast
8:00 am - 10:00 am | Presentations
10:00 am - 10:30 am | Q&A
Register for this seminar by Friday, February 6, 2015.