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Friday, March 6, 2026
8:00 AM - 9:00 AM
East Coast USA Time
Networking Breakfast
8:00 AM - 9:00 AM
East Coast USA Time
Networking Breakfast
8:30 AM - 9:00 AM
East Coast USA Time
Solutions Circle: How Can a Strong Quality System Support a Manufacturer's Regulatory Strategy?
8:30 AM - 9:00 AM
East Coast USA Time
Solutions Circle: How Can a Strong Quality System Support a Manufacturer's Regulatory Strategy?
Facilitator:
Florianne Torset-Bonfillou, RAC
– GMED North America
Medical Devices
8:30 AM - 9:00 AM
East Coast USA Time
Solutions Circle: Managing the Lifecycle for Artificial Intelligence in Medicine
8:30 AM - 9:00 AM
East Coast USA Time
Solutions Circle: Managing the Lifecycle for Artificial Intelligence in Medicine
Facilitator:
Erez Kaminski, N/A (he/him/his)
– Ketryx
Medical Devices
8:30 AM - 9:00 AM
East Coast USA Time
Solutions Circle: Navigating the Post-Market Cybersecurity Maze: Managing Vulnerabilities in Complex Medical Devices
8:30 AM - 9:00 AM
East Coast USA Time
Solutions Circle: Navigating the Post-Market Cybersecurity Maze: Managing Vulnerabilities in Complex Medical Devices
Facilitator:
Gabriel Pascualy, None
– Ketryx
Medical Devices
9:15 AM - 10:15 AM
East Coast USA Time
From Insight to Impact: A Practical Guide to Reviewing and Shaping Regulatory Guidance
9:15 AM - 10:15 AM
East Coast USA Time
From Insight to Impact: A Practical Guide to Reviewing and Shaping Regulatory Guidance
Presenter:
Jonali N. Ramani, RAC
– organon
Pharmaceuticals & Biologics
9:15 AM - 10:15 AM
East Coast USA Time
QMS for Adaptive AI/ML Devices: What You Can’t Miss
9:15 AM - 10:15 AM
East Coast USA Time
QMS for Adaptive AI/ML Devices: What You Can’t Miss
Presenter:
Jenn Dixon, N/A (she/her/hers)
– Ketryx
Medical Devices
10:15 AM - 10:45 AM
East Coast USA Time
Coffee & Refreshment Break
10:15 AM - 10:45 AM
East Coast USA Time
Coffee & Refreshment Break
10:45 AM - 11:45 AM
East Coast USA Time
Devices that Help: Demystifying the Regulatory Expectations Around Showing “Benefit”
10:45 AM - 11:45 AM
East Coast USA Time
Devices that Help: Demystifying the Regulatory Expectations Around Showing “Benefit”
Presenter:
Bethany Chung, PhD, RAC
– RQM+
Medical Devices
10:45 AM - 11:45 AM
East Coast USA Time
No Site, No Problem? Regulating Evidence in a Decentralized Trial World
10:45 AM - 11:45 AM
East Coast USA Time
No Site, No Problem? Regulating Evidence in a Decentralized Trial World
Presenter:
Odette Hauke, MS
– Vera Therapeutics
Pharmaceuticals & Biologics
12:00 PM - 1:00 PM
East Coast USA Time
Cybersecurity and Data Integrity in Cloud-Based Regulatory Submissions
12:00 PM - 1:00 PM
East Coast USA Time
Cybersecurity and Data Integrity in Cloud-Based Regulatory Submissions
Presenter:
Srividya Narayanan, MS, CQSP (she/her/hers)
– Northeastern University
Medical Devices
12:00 PM - 1:00 PM
East Coast USA Time
Global Registration Planning Consideration: Integrated Strategy to Solve the Complex Registration Sample Challenge
12:00 PM - 1:00 PM
East Coast USA Time
Global Registration Planning Consideration: Integrated Strategy to Solve the Complex Registration Sample Challenge
Presenter:
Kingman Ng, PhD
– Eli Lilly and Company
Pharmaceuticals & Biologics
1:00 PM - 2:00 PM
East Coast USA Time
Lunch and Sponsored Presentations
1:00 PM - 2:00 PM
East Coast USA Time
Lunch and Sponsored Presentations
2:00 PM - 3:00 PM
East Coast USA Time
Chasing an Easier Method for Specific PMPF: Can Surveys Play a Role?
2:00 PM - 3:00 PM
East Coast USA Time
Chasing an Easier Method for Specific PMPF: Can Surveys Play a Role?
Presenter:
Bethany Chung, PhD, RAC
– RQM+
Presenter:
Anastassia Young, MS
– RQM+
Presenter:
Red Thaddeus D. Miguel, MD, MBA, MSc (Oxon), RAC, RCC
– Thera-Business Inc.
2:00 PM - 3:00 PM
East Coast USA Time
Integrated Approach to CTD Module 3 Submission for Drug-Device Combination Products
2:00 PM - 3:00 PM
East Coast USA Time
Integrated Approach to CTD Module 3 Submission for Drug-Device Combination Products
Presenter:
Fubin Wu, MS
– GessNet
Presenter:
James Wabby, BSc., MHMS
– AbbVie
Presenter:
Hrishikesh (Rishi) Khatav, MS, RAC
– NPD Wearable Injectors + Innovation
Presenter:
Douglass S. Mead, III, RAC
– CP Pathways LLC
Combination Products
3:00 PM - 3:30 PM
East Coast USA Time
Afternoon Refreshment Break
3:00 PM - 3:30 PM
East Coast USA Time
Afternoon Refreshment Break
3:30 PM - 4:30 PM
East Coast USA Time
Closing Plenary: The Compliance Matrix: Futureproofing Regulatory Professionals in the Age of AI
3:30 PM - 4:30 PM
East Coast USA Time
Closing Plenary: The Compliance Matrix: Futureproofing Regulatory Professionals in the Age of AI
Moderator:
Geethapriya K. Setty, RAC Medical Devices (she/her/hers)
– Hologic Inc
Panelist:
Monika McDole-Russell, MS, RAC (she/her/hers)
– Intuitive Surgical
Panelist:
Amra Racic
– Veeva MedTech
Panelist:
Jay Vaishnav, PhD, RAC-Devices, FRAPS (she/her/hers)
– Canon Medical Informatics, Inc.
Medical Devices