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Thursday, April 24, 2025
7:00 AM – 8:00 AM
East Coast USA Time
Breakfast
7:00 AM – 8:00 AM
East Coast USA Time
Breakfast
8:00 AM – 8:10 AM
East Coast USA Time
Opening Day 2
8:00 AM – 8:10 AM
East Coast USA Time
Opening Day 2
Speaker:
Kim Belsky
– AFDO/RAPS Healthcare Products Collaborative
Plenary
8:15 AM – 9:30 AM
East Coast USA Time
Breaking Barriers: The Power of Regulatory Reliance
8:15 AM – 9:30 AM
East Coast USA Time
Breaking Barriers: The Power of Regulatory Reliance
Moderator:
Fatemeh Razjouyan
– Medtronic
Plenary
9:30 AM – 9:50 AM
East Coast USA Time
BREAK
9:30 AM – 9:50 AM
East Coast USA Time
BREAK
9:55 AM – 11:25 AM
East Coast USA Time
Breakout #1: Risk Management - TBD
9:55 AM – 11:25 AM
East Coast USA Time
Breakout #1: Risk Management
Moderator:
Shannon Hoste
– Pathway for Patient Health
Breakout
9:55 AM – 11:25 AM
East Coast USA Time
Breakout #2: One Year Into FDA’s New Regulatory Authority of Medical Device Cybersecurity + A Cybersecurity Regulatory Landscape Update
9:55 AM – 11:25 AM
East Coast USA Time
Breakout #2: One Year Into FDA’s New Regulatory Authority of Medical Device Cybersecurity + A Cybersecurity Regulatory Landscape Update
Moderator:
Eric Henry
– King & Spalding
Breakout
9:55 AM – 11:25 AM
East Coast USA Time
Breakout #3: Due Diligence – Are You Doing Enough? What About After Acquisition?
9:55 AM – 11:25 AM
East Coast USA Time
Breakout #3: Due Diligence – Are You Doing Enough? What About After Acquisition?
Moderator:
Monica Wilkins
– Abbott
Breakout
11:25 AM – 12:25 PM
East Coast USA Time
LUNCH
11:25 AM – 12:25 PM
East Coast USA Time
LUNCH
12:30 PM – 2:00 PM
East Coast USA Time
Breakout # 2: QMSR – Are You Ready?
12:30 PM – 2:00 PM
East Coast USA Time
Breakout #1: Addressing 510(k) Review Challenges
Moderator:
Bill Brodbeck
– STERIS Corporation
Moderator:
Heather Rosecrans
– Eliquent Life Sciences | Vice President Regulatory Affairs, MDMA
Breakout
12:30 PM – 2:00 PM
East Coast USA Time
Breakout #1: Addressing 510(k) Review Challenges
12:30 PM – 2:00 PM
East Coast USA Time
Breakout #2 QMSR Are You Ready?
Breakout
12:30 PM – 2:00 PM
East Coast USA Time
Breakout #3: Are You Processing and Investigating Complaints to the Right Level?
12:30 PM – 2:00 PM
East Coast USA Time
Breakout #3: Are You Processing and Investigating Complaints to the Right Level?
Moderator:
Gina Brackett
– FDA (Invited)
Breakout
2:00 PM – 2:20 PM
East Coast USA Time
BREAK
2:00 PM – 2:20 PM
East Coast USA Time
BREAK
2:25 PM – 4:25 PM
East Coast USA Time
FDA Mock Inspection
2:25 PM – 4:25 PM
East Coast USA Time
FDA Mock Inspection
Moderator:
Phil Pontikos
– FDA (Invited)
Plenary
4:30 PM – 5:00 PM
East Coast USA Time
Patient Experience Plenary, #2 Exploring Patient Experience
4:30 PM – 5:00 PM
East Coast USA Time
Patient Experience Plenary #2
Moderator:
Shannon Hoste
– Pathway for Patient Health
Plenary
5:00 PM – 5:10 PM
East Coast USA Time
Day 2 Close
5:00 PM – 5:10 PM
East Coast USA Time
Day 2 Close
Speaker:
Kim Belsky
– AFDO/RAPS Healthcare Products Collaborative
Plenary
5:30 PM – 7:00 PM
East Coast USA Time
Networking Reception
5:30 PM – 7:00 PM
East Coast USA Time
Networking Reception
Networking Event