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Thursday, April 23, 2026
7:00am - 8:00am
East Coast USA Time
020 - Breakfast
7:00am - 8:00am
East Coast USA Time
Breakfast
7:00am - 5:00pm
East Coast USA Time
021 - Registration
7:00am - 5:00pm
East Coast USA Time
Registration
8:00am - 8:10am
East Coast USA Time
022 - Day 2 Open
8:00am - 8:10am
East Coast USA Time
Day 2 Open
Plenary
8:10am - 10:10am
East Coast USA Time
023 - QMSR Implementation Update
8:10am - 8:45am
East Coast USA Time
QMSR Implementation Update
Moderator:
Susan Matthias
– FDA
Speaker:
Karen Masley-Joseph
– FDA
Speaker:
Keisha Thomas
– FDA
Plenary
8:45am - 10:10am
East Coast USA Time
024 - Updated Compliance Program (CP) for Inspection of Medical Device Manufacturers
8:45am - 10:10am
East Coast USA Time
Updated Compliance Program (CP) for Inspection of Medical Device Manufacturers
Moderator:
Susan Matthias
– FDA
Speaker:
Gina Brackett
– FDA
Speaker:
Michelle Glembin
– FDA
Speaker:
Bryan Love
– FDA
Speaker:
Karen Masley-Joseph
– FDA
Speaker:
Debbie Reese
– FDA
Speaker:
Keisha Thomas
– FDA
Plenary
10:10am - 10:30am
East Coast USA Time
025 - BREAK
10:10am - 10:30am
East Coast USA Time
BREAK
10:30am - 12:30pm
East Coast USA Time
026 - Breakout #1: The Mechanics of an FDA Inspection: A View from Many Perspectives
10:30am - 12:30pm
East Coast USA Time
Breakout #1: The Mechanics of an FDA Inspection
Speaker:
CDR Cesar Perez
– FDA
Speaker:
Melissa Michurski
– FDA
Speaker:
Joe Strelnik
– FDA
Breakout
10:30am - 11:30am
East Coast USA Time
027 - Breakout #2: Horizontal legislation in EU, a complex growing web of supporting legislation
10:30am - 11:30am
East Coast USA Time
Breakout #2: EU MDR – State of Play and Targeted Revisions
Moderator:
Gert Bos
– Qserve Group
Moderator:
Kim Trautman
– Medical Device, IVD and Combo Product Expert
Speaker:
Philippe Auclair
– AKRA Team
Speaker:
Fabien Roy
– Arnold & Porter
Speaker:
Andreas Stange
– TUV SUD
Speaker:
Cécile van der Heijden
– Axon Lawyers
Breakout
11:30am - 12:30pm
East Coast USA Time
028 - Breakout #2: EU MDR – State of Play and Targeted Revisions
11:30am - 12:30pm
East Coast USA Time
Breakout #2: Horizontal Legislation in EU, A Complex Growing Web of Supporting Legislation
Moderator:
Gert Bos
– Qserve Group
Moderator:
Kim Trautman
– Medical Device, IVD and Combo Product Expert
Speaker:
Philippe Auclair
– AKRA Team
Speaker:
Fabien Roy
– Arnold & Porter
Speaker:
Andreas Stange
– TUV SUD
Speaker:
Cécile van der Heijden
– Axon Lawyers
Breakout
12:30pm - 1:30pm
East Coast USA Time
029 - LUNCH
12:30pm - 1:30pm
East Coast USA Time
LUNCH
1:30pm - 3:00pm
East Coast USA Time
030 - Breakout #1: CDRH Premarket Update
1:30pm - 3:00pm
East Coast USA Time
Breakout #1: CDRH Premarket Update
Moderator:
Heather Rosecrans
– MDMA & ELIQUENT Life Sciences
Moderator:
Bill Brodbeck
– STERIS Corporation
Speaker:
Clarence Murray, III
– STERIS Corporation
Speaker:
Josh Nipper
– FDA
Speaker:
Mike Ryan
– Eliquent Life Sciences
Breakout
1:30pm - 3:00pm
East Coast USA Time
031 - Breakout # 2: Bringing New Products to Life Compliantly: Challenges in Design Development
1:30pm - 3:00pm
East Coast USA Time
Breakout # 2: Quality Beyond the Factory’s Walls: Managing Supplier Risk and Quality From Off-the-Shelf to Custom Contract Manufactured Products
Moderator:
Gina Brackett
– FDA
Moderator:
John Krug
– Eli Lilly and Company
Moderator:
Susan Matthias
– FDA
Speaker:
James Brogan
– West Pharmaceutical Services
Speaker:
Maria Hult
– Roche Diagnostics
Speaker:
Janet Pulver
– U.S. FDA, Office of Inspections and Investigations
Speaker:
Katelyn Staub-Zamperini
– FDA
Breakout
3:00pm - 3:20pm
East Coast USA Time
032 - BREAK
3:00pm - 3:20pm
East Coast USA Time
BREAK
3:20pm - 4:35pm
East Coast USA Time
033 - Regulators: Global Harmonization and Convergence Initiatives
3:20pm - 4:35pm
East Coast USA Time
Global Regulatory Collaboration/Reliance Strategies, Alignment Challenges & “Relianomics” for Medical Devices
Moderator:
Kim Trautman
– Medical Device, IVD and Combo Product Expert
Speaker:
Lawrence Liberti
– D.K. Kim International Center for Regulatory Sciences at USC Officer
Speaker:
Olga van Grol-Lawlor
– Boston Scientific
Speaker:
Diane Wurzburger
– GE Healthcare
Plenary
4:35pm - 5:05pm
East Coast USA Time
034 - Patient Experience Plenary #2
4:35pm - 5:05pm
East Coast USA Time
Patient Experience Plenary #2
Moderator:
Jessica Zeller
– Edwards Lifesciences
Speaker:
Lori M. Jones
– Children's Heart Foundation
Plenary
5:05pm - 5:15pm
East Coast USA Time
0.35 - Day 2 Close
5:05pm - 5:15pm
East Coast USA Time
Day 2 Close
Plenary
5:15pm - 6:30pm
East Coast USA Time
036 - Networking Reception
5:15pm - 6:30pm
East Coast USA Time
Networking Reception
Networking Event
