Webinar: Health Canada Clinical Trials Regulatory Modernization
By Innomar Strategies
Health Canada has released a long-anticipated proposal to modernize the Canadian Clinical Trial regulatory framework — a change that would reshape how sponsors plan, prepare, and submit their applications. To help you stay ahead of the curve, Innomar is hosting a one-hour webinar outlining the key elements of the proposal and what these updates may mean for your upcoming clinical programs in Canada. This early-access briefing will be delivered by Adam Buffone and Michelle De La Croix, who will provide a balanced perspective from both former Health Canada leadership and experienced industry operations, giving attendees the context they need to begin planning strategically — without overwhelming detail.
If you support clinical development in Canada, this is a session you won’t want to miss.
Speakers
Adam Buffone
Director of Regulatory Affairs
Adam Buffone is Director of Regulatory Affairs at Innomar Strategies, a Cencora company, where he leverages 17 years of experience at Health Canada to support sponsors in navigating complex regulatory pathways and advancing clinical development programs.
Over nearly two decades in government, Adam rose from laboratory scientist to Associate Director and Acting Director of the Office of Clinical Trials and Special Access Program in the Pharmaceutical Drugs Directorate. He managed senior teams, signed off on high-stakes regulatory decisions, and routinely briefed Health Canada’s executive leadership on emerging issues.
With his track record of innovation, international influence, and hands-on regulatory leadership, Adam positions sponsors for success by bringing both strategic foresight and practical regulatory execution to every engagement.
Michelle De La Croix
Director/Consultant, Regulatory Affairs
Michelle De La Croix is Director Regulatory Affairs Consulting at Innomar Strategies. Michelle has worked within the Canadian Regulatory Affairs consulting area since 2002. Michelle has a vast experience with various therapeutics and biologics drugs. During this time, she has prepared drug submissions for Health Canada, Investigational Testing Applications for class 2 Medical Devices to Health Canada and prepared submissions of US Investigational New Drug applications to the FDA, all with positive regulatory decisions. As a consultant she has provided clarification of guidance documents and submission requirements for Health Canada, provided strategic advice to fast track timelines for submissions, helped create training modules and assisted companies to ensure product compliance.
Michelle’s specialized in Clinical Trial Application submissions to Health Canada for Pharmaceuticals, Biologics, Natural Health Products).
