Canada Annual Meeting

During this learning session, Health Canada speakers will discuss ongoing efforts to modernize Canada’s clinical trial regulatory framework in support of innovation, economic growth, and the protection of participant health and safety. Participants will learn about the proposed clinical trial regulations and how they aim to create a more modern, flexible, and risk-proportionate approach to the oversight of drug clinical trials throughout their lifecycle. The session will explore how the proposed framework is designed to better support complex and innovative clinical trial designs, including decentralized and technology-enabled trials, while improving access to clinical research opportunities across Canada. Speakers will also highlight key objectives of the proposed framework, including strengthening participant protection, enhancing the quality and reliability of clinical trial data, focusing regulatory oversight where risks are greatest, and increasing alignment with international regulatory standards. The session will provide insights into how these proposed changes could help foster a more efficient clinical trial environment and enable Canadians to benefit more quickly from advances in drug development and innovative therapies. The session will also provide an overview of the guidance documents, policies, and related initiatives that will support implementation of the proposed regulations. These measures are intended to help stakeholders understand regulatory expectations, promote a consistent approach to compliance, and support the adoption of innovative and efficient clinical trial practices.