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Thu, Mar 5
Fri, Mar 6
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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
Attendee Breakfast
Room: Harborview
8:00 AM - 12:00 PM
East Coast USA Time
Registration Hours
8:00 AM - 12:00 PM
East Coast USA Time
Registration Hours
Room: Atrium
8:30 AM - 9:00 AM
East Coast USA Time
Solutions Circle (1): Navigating the Post-Market Cybersecurity Maze: Managing Vulnerabilities in Complex Medical Devices
8:30 AM - 9:00 AM
East Coast USA Time
Solutions Circle (1): Navigating the Post-Market Cybersecurity Maze: Managing Vulnerabilities in Complex Medical Devices
Room: Annapolis
Facilitator:
Gabriel Pascualy, None
– Ketryx
Medical Devices
8:30 AM - 9:00 AM
East Coast USA Time
Solutions Circle (3): Global Regulatory Strategy for Orphan Early Stage Drug Development
8:30 AM - 9:00 AM
East Coast USA Time
Solutions Circle (3): Global Regulatory Strategy for Orphan Early Stage Drug Development
Room: Columbia
Facilitator:
Tina Kim-Hafken, MSc
– Immunome, Inc.
Pharmaceuticals & Biologics
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
Room: Constellation CD
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
Room: Constellation EF
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
Room: Harborview
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”
Room: Constellation CD
Presenter:
Bethany Chung, PhD, RAC
– RQM+
Medical Devices
10:45 AM - 11:45 AM
East Coast USA Time
Regulatory Challenges Demystified: Tips, Tools, and Expert Advice
10:45 AM - 11:45 AM
East Coast USA Time
Regulatory Challenges Demystified: Tips, Tools, and Expert Advice
Room: Constellation EF
Presenter:
Daniela Drago, PhD, RAC, FRAPS
– NDA Partners
Pharmaceuticals & Biologics
12:00 PM - 1:00 PM
East Coast USA Time
New Video
Cybersecurity and Data Integrity in Cloud-Based Regulatory Submissions
12:00 PM - 1:00 PM
East Coast USA Time
New Video
Cybersecurity and Data Integrity in Cloud-Based Regulatory Submissions
Room: Constellation CD
Presenter:
Srividya Narayanan, MS, CQSP (she/her/hers)
– Asahi Intecc
Medical Devices
12:00 PM - 1:00 PM
East Coast USA Time
NEW
Discussions on Critical Issues
12:00 PM - 1:00 PM
East Coast USA Time
NEW
Discussions on Critical Issues
Room: Constellation CD
Panelist:
Chang-Hong Whitney, RAC, MBA
– Whitney Consulting Ltd.
Panelist:
Bethany Chung, PhD, RAC
– RQM+
Panelist:
Hemang Kotecha, MS, RAC
– Medtronic
Panelist:
Jay Vaishnav, PhD, RAC-Devices, FRAPS (she/her/hers)
– Canon Medical Informatics, Inc.
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
Room: Constellation EF
Presenter:
Kingman Ng, PhD
– Eli Lilly and Company
Pharmaceuticals & Biologics
1:00 PM - 2:00 PM
East Coast USA Time
Lunch Break
1:00 PM - 2:00 PM
East Coast USA Time
Lunch Break
Room: Harborview
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?
Room: Constellation CD
Presenter:
Bethany Chung, PhD, RAC
– RQM+
Presenter:
Anastassia Young, MS (she/her/hers)
– RQM+
Presenter:
Red Thaddeus D. Miguel, MD, MBA, MSc (Oxon), RAC, RCC
– Thera-Business Inc.
IVD
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
Room: Constellation EF
Presenter:
Fubin Wu, MS
– GessNet
Presenter:
James Wabby, BSc., MHMS
– AbbVie
Presenter:
Hrishikesh (Rishi) Khatav, MS, RAC
– Becton Dickinson & Co.
Presenter:
Douglass S. Mead, III, RAC
– CP Pathways LLC
Moderator:
Heather Guerin, PhD, PE (she/her/hers)
– Novartis
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
Room: Harborview
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
Room: Constellation EF
Moderator:
Geethapriya K. Setty, MS., MBA., RAC- 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