Canada Annual Meeting

Each day’s networking luncheon offers both open seating and focused roundtable discussions. Each topic listed below will be hosted at a designated table led by a moderator. If you’re passionate about one of these subjects or would like to exchange ideas with peers who share similar interests, we invite you to join a designated table to enjoy both your meal and an engaging conversation.

T&C Implementation and Further Discussion hosted by Kristen Zorn, Health Canada
This fall, Health Canada will be consulting on two guidance documents that explain the new broad terms and conditions (T&C) authorities that will come into effect on April 1, 2027. The Roundtable session will be an opportunity to ask questions about how T&Cs will be implemented, including the processes and timing, and how T&Cs for submissions based on promising evidence of efficacy will replace the current Notice of Compliance with Conditions policy.

More on Health Canada’s Management of Workload and Backlog hosted by Elana Cherry, Health Canada
At the DIA Canada Annual 2025 Meeting, Health Canada will present an overview of its current challenges and strategic responses related to the growing backlog in drug submissions. Since 2022, both the Pharmaceutical Drugs Directorate (PDD) and the Biologic and Radiopharmaceutical Drugs Directorate (BRDD) have experienced significant increases in submission volume and complexity, compounded by staffing limitations and incomplete data packages. Despite internal efficiency measures, capacity constraints have persisted, prompting increased feedback from industry stakeholders requesting greater predictability and transparency, enhanced flexibility in the review process, stronger international collaboration, and timely updates to guidance and policy. Stakeholder workshops held in September led to a collaborative action plan focused on transparency, communication improvements, and increased flexibility. The roundtable discussion is an opportunity for more detailed discussion about shared responsibility, ongoing engagement, and balancing short-term actions with long-term sustainability. Health Canada looks forward to hearing your thoughts and ideas as part of this ongoing dialogue

What is your Regulatory Affairs Career Development Path? hosted by My Dang, Cencora, Marcia Sam, Regeneron and Melanie Cote, Otsuka Pharmaceutical Development & Commercialization Inc.
3 Regulatory Affairs professionals will be briefly sharing their experience in regulatory affairs and answering any question the attendees would have to give them ideas for their own career development.

Meet Your Health Canada Clinical Trial Reviewers: Collaborating Towards a Successful Clinical Trial Application hosted by Katherine Soltys,
Health Canada and Sophie Hamel, Health Canada To answer any questions you may have on Health Canada’s clinical trial application (CTA) process, representatives from Health Canada’s Office of clinical trials will host a roundtable on the preparation for a successful CTA

Canada on the International Stage hosted by Kelly Robinson, Health Canada
Kelly Robinson (Director General, PDD) would discuss topics related to Health Canada’s participation in various international collaboration initiatives.