This webinar will provide a timely overview of the U.S. Department of Health and Human Services’ (HHS) AI strategy and examine how the FDA is implementing advanced AI tools in regulatory review. Attendees will gain practical insights into evolving legal and compliance requirements, operational best practices, and the implications of AI for sponsors and stakeholders in the life sciences sector.
Key Topics
- HHS’s AI vision, strategic pillars, and compliance mandates
- FDA’s use of generative and agentic AI in regulatory processes
- Legal safeguards for confidentiality and transparency
- Operational readiness and best practices for AI-enabled review
- Recommendations for engaging with HHS and FDA on AI policy
Presenters
Kimberly I. Chew, Attorney
Odette Hauke, Principal Consultant, Global Regulatory Affiairs, Odette Alina, LLC.
Who Should Attend
Regulatory affairs and compliance leaders; general counsel and in-house legal teams; healthcare and life sciences professionals overseeing regulatory, privacy, or policy matters; clinical research and R&D leaders involved in FDA submissions; health system compliance and IT leads; digital health, medtech, and health IT professionals; data privacy officers and data science teams supporting regulated products; AI/ML developers and vendors working in regulated industries or with FDA/HHS; and law firms, consultants, and government affairs professionals focusing on healthcare regulation.
Continuing Education Credit
This program is pending approval for Colorado, Illinois, Iowa, Kansas, Missouri, Minnesota, Nebraska, Pennsylvania, Tennessee, Texas, and Wisconsin continuing legal education credit.
Did you miss the webinar?
The webinar recording is available after the event date. Simply register using this on-demand link to access the recorded program.
Questions?
Contact Morgan Buciumean at 303.749.7281.