This session will provide insights on moving from the traditional regulatory strategies for mature technologies to the new regulatory strategies for novel uses of AI and ML while engaging FDA and/or Notified Bodies in the effort. The IMDRF, US and EU perspectives on what's next for AI and ML as SaMD will be explored.
Why you should Attend:
This session will engage professionals looking to understand the regulatory challenges of software as a medical device (SaMD) with special focus on AI/Machine Learning (ML).
Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services.
Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds. Past employers / clients include Royal Berkshire Hospital, Roche, Novartis, Genentech, PriceWaterhouseCoopers & Stanford Hospital. Positions include Chief Compliance Officer,Director of QA and MIS Director.
- VP of IT
- Director of IT
- Quality Managers
- Project Managers (for CSV/IT)
- Validation Specialists
- Database Administrators
- System Administrators
- Directors/Senior Directors of Discovery
- Directors/Senior Directors of Development
- Directors/Senior Directors of Commercialization
- Document Managers
- Training Managers