Latest Developments and Issues in Health Product Regulations

Vancouver, BC (PST)

Fasken Martineau
2900 - 550 Burrard Street
Vancouver, BC

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.

Why attend:

  • 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.