Day One – November 5, 2024
- Daphne King - Associate Director, Regulatory CMC, formerly with BioMarin Pharmaceutical Inc
Current regulatory pathways for MDSW in the US
How do they compare to EU’s regulations?
Common pain point for industry
Case study – successful MDSW approval
What’s on the horizon?
FDA priorities for the year ahead
- Matt Trachtenberg - Senior Director of Regulatory Affairs, Tempus AI
Defining AI/ML
Latest update on regulatory pathways for AI/ML
Comparison to Europe’s regulations
Can you leverage data from one region to the other?
Current experiences with gaining AI/ML certification
- Abhineet Jhori - Regulatory Affairs Manager, Siemens Healthineers
Latest update on the implementation of the AI Act
When is it expected to go into law?
Interaction between the Act and the MDR and IVDR?
Link to data protection laws
Difference in obligations based on risk level
How will the implementation affect all stakeholders?
Forward thinking
Can we expect further regulations as AI develops?
- Andreas Stange - Senior Vice President MHS Regulatory & Quality, TÜV SÜD Product Service GmbH
- Sravani Sreeram Nagasai - Technical Program Manager, Google
How to apply risk management principles for AI in Medical devices?
TIR 34971:2023 application of ISO 14971 to machine learning in artificial intelligence.
Identification of Hazards
Risk evaluation.
Risk control.
Risk review & post market risk monitoring
- Arun Mathew - Associate Director, Quality Systems (Risk Management), AbbVie
- Sabyasachi Roy - Head of Regulatory Affairs - Enterprise Informatics, Innovation & Strategy, Philips
Decoding the latest FDA cybersecurity guidance
Defining cybersecurity
What's changed from the previous version?
How does this guidance compare to other global markets?
Are there further implications for industry?
Putting guidance into practice – effective implementation of cybersecurity guidelines
- Nidhi Gani - Medical Device Cybersecurity Fellow, Archimedes Center for Health Care and Medical Device Cybersecurity at Northeastern University
- Daphne King - Associate Director, Regulatory CMC, formerly with BioMarin Pharmaceutical Inc
What are the current requirements of PCCP for AI/ML-enabled devices?
Is it just for AI/ML-enabled devices?
Can, and how could, companies leverage these for other uses, such as software or material changes?
Update on FDA’s proposed guidance on PCCP
How does this filter into other regions, such as Europe and Canada?
- Bill Kurani - SVP Regulatory Affairs, Clinical Affairs, and Quality Assurance, Antrix
Current global standards for clinical data for AI/ML devices
What do regulators and notified bodies expect?
Do they differ regionally?
Data collection and analysis in practice: end-to-end case study
Key regulations/standards to consider
Compilation of documentation
Common pitfalls and methods to overcome
- Cécile van der Heijden - Senior Attorney-at-Law, Axon Lawyers
How can AI enhance working practice efficiency?
Automation of regulatory processes
Generative-AI in translations
Associated risks
How can you predict and mitigate risks with AI incorporation?
Forward thinking – what does increased AI incorporation mean for regulatory teams?
- Raeesa Gupte - Senior Clinical Scientist, Intuitive
Interpreting regulations
Where are we with AI/ML based Software As a Medical Device (SaMD) regulations globally to assure patient safety?
Industry case study
Risk-based approach for developing AI/ML and LLM based health technologies
- Foward-thinking
Adapting AI/ML and LLM based devices in an evolving regulatory landscape
- Rachel Chu - Quality Engineering Manager, Verily
- Aarthi Srinivasan - Regulatory Affairs, Verily
With MDSW and AI/ML changing rapidly, what can we expect in the next 5 years for regulating these types of devices and diagnostics?
Priorities for the immediate and more distance future
Harmonisation across regions
How can we be preparing regulatory teams for future changes?
- Nidhi Gani - Medical Device Cybersecurity Fellow, Archimedes Center for Health Care and Medical Device Cybersecurity at Northeastern University
- Cécile van der Heijden - Senior Attorney-at-Law, Axon Lawyers
- Scott Thiel - Corporate Head of Regulatory Affairs, Hologic
- Sabyasachi Roy - Head of Regulatory Affairs - Enterprise Informatics, Innovation & Strategy, Philips