Artificial Intelligence (AI) is revolutionizing industries, and its potential in regulatory sciences is vast. During the 2024 DIA Canada Annual Meeting Conference, Benny Ling – Senior Scientific Evaluator, Marketed Pharmaceuticals Bureau at Health Canada, highlighted the evolving role of AI in regulatory frameworks, with applications spanning data analysis, process optimization, and pharmacovigilance. Here’s how these advancements could reshape regulatory practices and how Zenith PV can help your organization navigate these changes:
Key Takeaways from Health Canada’s Presentation
- Current Landscape of AI in Canada:
- Algorithmic Impact Assessment (AIA): This mandatory tool identifies risks associated with automated decision systems, emphasizing transparency and fairness.
- Artificial Intelligence and Data Act (AIDA): Establishes a framework for designing responsible AI systems.
- International AI Collaborations:
- Health Canada collaborates globally to establish harmonized principles for AI in medical devices and pharmaceuticals.
- The CIOMS Working Group focuses on AI’s role in pharmacovigilance, addressing challenges like bias, transparency, and data privacy.
- Pre-Market Guidance for AI-Enabled Devices:
- Early guidance for machine-learning models ensures safety and efficacy before market entry, setting the stage for future AI-driven pharmaceutical innovations.
Actionable Insights for Industry Stakeholders
- Prepare for AI Integration:
- Adopt tools like AIA to assess risks in your AI applications.
- Build robust governance frameworks to manage AI-related challenges, including explainability and bias.
- Leverage Global Standards:
- Align your processes with international guidance, such as Health Canada’s collaboration with the IMDRF and WHO recommendations.
- Optimize Pharmacovigilance with AI:
- Implement machine learning to detect patterns in adverse events and optimize safety monitoring processes.
How Zenith PV Can Help
- Conduct AI readiness assessments for your pharmacovigilance systems.
- Develop tailored strategies to align your processes with evolving AI regulations.
- Provide training on implementing AI tools responsibly in compliance with Canadian and international guidelines.
Disclaimer
This post reflects Zenith PV’s interpretation of the regulatory landscape and does not represent the views of Health Canada or other agencies.