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Wednesday, Apr 23rd
1:20 PM – 2:35 PM East Coast USA Time
Breakout #1: International: Experience and Challenges With MDR/IVDR and EUDAMED
Moderator: Gert Bos – Qserve Group
Moderator: Kim Shoemaker – Johnson & Johnson MedTech
Speaker: Sabina Hoekstra-van den Bosch – TÜV SÜD Medical Health Services
Breakout
Wednesday, Apr 23rd
1:20 PM – 2:35 PM East Coast USA Time
Breakout #2: Implementation of Artificial Intelligence in Manufacturing and the Quality System
Moderator: Eric Henry – King & Spalding
Breakout
Wednesday, Apr 23rd
1:20 PM – 2:35 PM East Coast USA Time
Breakout #3: What’s New in CDRH Premarket Programs: Insights and Updates From FDA and Industry Experts
Moderator: Heather Rosecrans – Eliquent Life Sciences | Vice President Regulatory Affairs, MDMA
Speaker: Mark Leahey – Medical Device Manufacturers Association (MDMA)
Speaker: Josh Nipper – FDA (Invited)
Speaker: Dan Schultz – Eliquent Life Sciences
Breakout
Wednesday, Apr 23rd
2:55 PM – 3:55 PM East Coast USA Time
Breakout #1: Optimizing Regulatory and Design Strategies for LDTs and IVDs with Different International Requirements
Moderator: Kim Trautman – Medical Device, IVD and Combo Product Expert
Speaker: Ken Fuh – ACT-IVD
Speaker: Michelle Zaharik – MLZ Biotech Consulting Inc
Speaker: Balazs Bozsik – SGS North America Inc.
Breakout
Wednesday, Apr 23rd
2:55 PM – 3:55 PM East Coast USA Time
Breakout #2: Supply Chain Resiliency: Evolving Challenges and Best Practices
Moderator: Bill Brodbeck – STERIS Corporation
Speaker: Tammy Beckham – FDA (invited)
Speaker: Michael Gallucci – Edwards Lifesciences
Speaker: Matt Graf – Cook Medical
Breakout
Wednesday, Apr 23rd
2:55 PM – 3:55 PM East Coast USA Time
Breakout #3: Are You Correctly Assessing Quality System Activities When Quality System Functions Are Spread Out Across Different Locations?
Moderator: Gina Brackett – FDA (Invited)
Speaker: Monica Wilkins – Abbott
Speaker: Kim Shoemaker – Johnson & Johnson MedTech
Breakout
Thursday, Apr 24th
9:55 AM – 11:25 AM East Coast USA Time
Breakout #1: Risk Management - Systems Perspective
Moderator: Shannon Hoste – Pathway for Patient Health
Speaker: Brian Siroka – MEDIcept
Speaker: Evan Markley – Eli Lilly and Company
Breakout
Thursday, Apr 24th
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
Speaker: Axel Wirth – MedCrypt
Speaker: Justin Post – FDA (Invited)
Speaker: Chris Reed – Medtronic
Breakout
Thursday, Apr 24th
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
Thursday, Apr 24th
12:30 PM – 2:00 PM East Coast USA Time
Breakout #2 QMSR Are You Ready?
Breakout
Thursday, Apr 24th
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
Speaker: Clarence Murray III – STERIS Corporation
Speaker: Tony Piotrkowski – Steris
Speaker: Lisa Vincent Griffin – GT Metabolic Solutions
Breakout
Thursday, Apr 24th
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)
Speaker: Monica Wilkins – Abbott
Speaker: Aaron Dunbar – Boston Scientific
Speaker: Phil Pontikos – FDA
Breakout