Don’t miss the opportunity to enhance your professional knowledge and skills at the CAPRA Regulatory Affairs Symposium!

Day 1 Description:  This regulatory technology event highlights exciting discussions on the future of the regulatory landscape, exploring international regulatory modernization and its potential impact on Canada, as well as Canadian-focused regulatory modernization through collaboration and innovation.

We are pleased to welcome Kelly Robinson, Director General and Senior Executive Director at Health Canada, to open the event, which will cover a range of key initiatives.

 Many of our leading industry experts, along with speakers from Health Canada, will help attendees explore the latest ICH topics, trusted regulatory areas, advanced technological solutions, and the evolving regulatory landscape. We will also hear about Health Canada’s AI journey, how to achieve real-time exchange and review using FHIR, APIs, and AI, and how global AI regulations influence the use of AI in regulatory decision-making across the life sciences and healthcare sectors, including the impacts of different AI model types. These topics aim to foster dialogue and understanding between Health Canada and companies in a rapidly changing regulatory environment.

Day 2 Description:  Join CAPRA and Health Canada for an engaging symposium focused on building high-quality regulatory submissions that support more efficient reviews and timely access to medicines in Canada. Through updates from Health Canada review programs and perspectives from generic, biologic, biosimilar, and branded pharmaceutical stakeholders, attendees will gain practical insight into common submission challenges, recurring deficiencies, backlog-reduction initiatives, and opportunities to improve predictability, consistency, and collaboration across the submission lifecycle.

The program is designed to be highly interactive, with roundtable discussions facilitated by Health Canada and informed by pre-shared questions and attendee input. Participants will have the opportunity to exchange ideas, raise concerns, explore practical solutions, and leave with clearer expectations for stronger submissions. Whether you work in regulatory affairs, quality, compliance, or submission strategy, this event offers a valuable forum to connect with peers and regulators while contributing to shared improvements in Canada’s regulatory review process.

We encourage you to attend this event in person and to share it with your colleagues across R&D, RA, and quality groups to gain insights, share ideas, and improve submission success.