Back to Agenda
Session 1 Plenary: The Future of Therapeutic Products Development: Current Emerging Trends and Technologies
Session Chair(s)
Yatika Kohli, PhD, MBA
Chief Regulatory and Strategy Officer
NoNO Inc, Canada
Oxana Iliach, PhD
Senior Director Regulatory Strategy
Certara, Canada
Artificial Intelligence (AI) and Machine Learning (ML) have great potential to enhance drug development in many ways, including to help bring safe and effective drugs to patients faster; provide broader access to drugs and thereby improve health equity; increase the quality of manufacturing; enhance drug safety; and develop novel drugs and drug classes, as well as personalized treatment approaches. In this plenary session, representatives from industry, Health Canada and FDA will discuss impact of AI/ML on the development of therapeutic products and medical devices. This will be an interactive session, where participants will have an opportunity to ask questions on the latest regulatory requirements in this area.
Learning Objective : At the conclusion of this session, participants should be able to:- Describe challenges and opportunities presented by AI and ML
- Discuss areas of product development where AI and ML could be applied
- Explain Health Canada and FDA regulatory expectations for AI and ML
Speaker(s)
FDA Approach to Artificial Intelligence/Machine Learning-Enabled Medical Devices
Sonja Fulmer, PhD
FDA, United States
Deputy Director, Digital Health Center of Excellence, CDRH
Health Canada’s Pre-Market Draft Guidance for Machine Learning-enabled Medical Devices
Tyler Dumouchel, PhD, MSc
Health Canada, Canada
Senior Scientific Evaluator
Can’t ChatGPT Do That? Practical Applications for AI in Life Sciences
Sean McGee, MS
Certara, United States
Director of Product
Panelist
Rajeswari Devanathan, MSc
Cencora, Innomar Strategies, Canada
Senior Manager - Medical Devices
Have an account?