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Breaking Barriers: The Power of Regulatory Reliance

Fatemeh Razjouyan – Medtronic ### 2544314###Moderator###Director of Regulatory Policy, International and Harmonization | Global Regulatory Policy###Medtronic###
Moderator: Fatemeh Razjouyan – Medtronic
### @@@ Karen Noffs – Anvisa - Brazil ### 2591584###Speaker###Head of Pre-Market Approval of Medical Device ###Anvisa - Brazil###
Speaker: Karen Noffs – Anvisa - Brazil
### @@@ Tammy Steuerwald – Roche ### 2591593###Speaker###Global Head of Regulatory Policy, Foundational Principles and Supranational Organizations###Roche###
Speaker: Tammy Steuerwald – Roche
###
Breakout #1: QMSR - Are You Ready?

Monica Wilkins – Abbott ### 2544317###Moderator###VP Regulatory, Quality & Compliance###Abbott###
Moderator: Monica Wilkins – Abbott
### @@@ Kim Shoemaker – Johnson & Johnson MedTech ### 2544967###Moderator###Senior Director, Global Regulatory Affairs###Johnson & Johnson MedTech###
Moderator: Kim Shoemaker – Johnson & Johnson MedTech
### @@@ Meera Bhatia – Abbott ### 2622416###Speaker###Divisional Vice President Quality###Abbott###
Speaker: Meera Bhatia – Abbott
### @@@ Patrick Weixel – Abbott ### 2622417###Speaker###Director Quality###Abbott###
Speaker: Patrick Weixel – Abbott
###
Breakout #1: One Year Into FDA’s New Regulatory Authority of Medical Device Cybersecurity + A Cybersecurity Regulatory Landscape Update

Eric Henry – King & Spalding LLP ### 2482790###Moderator###Senior Quality & Regulatory Compliance Advisor, FDA & Life Sciences Practice###King & Spalding LLP###
Moderator: Eric Henry – King & Spalding LLP
### @@@ Axel Wirth – MedCrypt ### 2591604###Speaker###Chief Security Strategist###MedCrypt###
Speaker: Axel Wirth – MedCrypt
### @@@ Chris Reed – Medtronic ### 2591588###Speaker###Senior Director of Cybersecurity Policy, Global Regulatory Affairs###Medtronic###
Speaker: Chris Reed – Medtronic
###
Breakout #1: International: Experience and Challenges With MDR/IVDR and EUDAMED

Gert Bos – Qserve Group ### 2544966###Moderator###Executive Director & Partner###Qserve Group###
Moderator: Gert Bos – Qserve Group
### @@@ Kim Shoemaker – Johnson & Johnson MedTech ### 2544967###Moderator###Senior Director, Global Regulatory Affairs###Johnson & Johnson MedTech###
Moderator: Kim Shoemaker – Johnson & Johnson MedTech
### @@@ Sabina Hoekstra-van den Bosch – TÜV SÜD Medical Health Services ### 2591571###Speaker###Global Director Regulatory Strategy###TÜV SÜD Medical Health Services###
Speaker: Sabina Hoekstra-van den Bosch – TÜV SÜD Medical Health Services
### @@@ Nick-Roy Green – Johnson & Johnson MedTech ### 2633875###Speaker###Associate Director of Regulatory Affairs###Johnson & Johnson MedTech###
Speaker: Nick-Roy Green – Johnson & Johnson MedTech
###
Breakout #1: Optimizing Regulatory and Design Strategies for LDTs and IVDs with Different International Requirements

Kim Trautman – Medical Device, IVD and Combo Product Expert ### 2544312###Moderator###Expert###Medical Device, IVD and Combo Product Expert###
Moderator: Kim Trautman – Medical Device, IVD and Combo Product Expert
### @@@ Balazs Bozsik – SGS North America Inc. ### 2607208###Speaker###Technical Director - Medical Audit###SGS North America Inc.###
Speaker: Balazs Bozsik – SGS North America Inc.
### @@@ Ken Fuh (he/him/his) – ACT-IVD ### 2591570###Speaker###IVD and MDSW Expert###ACT-IVD###
Speaker: Ken Fuh (he/him/his) – ACT-IVD
### he/him/his @@@ David Murray – Illumina ### 2617827###Speaker###Senior Director, Quality###Illumina###
Speaker: David Murray – Illumina
### @@@ Michelle Zaharik – MLZ Biotech Consulting Inc ### 2591605###Speaker###Independent Expert###MLZ Biotech Consulting Inc###
Speaker: Michelle Zaharik – MLZ Biotech Consulting Inc
###
Breakout #2: Are You Correctly Assessing Quality System Activities When Quality System Functions Are Spread Out Across Different Locations?

Gert Bos – Qserve Group ### 2544966###Moderator###Executive Director & Partner###Qserve Group###
Moderator: Gert Bos – Qserve Group
### @@@ Monica Wilkins – Abbott ### 2544317###Speaker###VP Regulatory, Quality & Compliance###Abbott###
Speaker: Monica Wilkins – Abbott
### @@@ Kim Shoemaker – Johnson & Johnson MedTech ### 2544967###Speaker###Senior Director, Global Regulatory Affairs###Johnson & Johnson MedTech###
Speaker: Kim Shoemaker – Johnson & Johnson MedTech
###
Breakout #2: Are You Processing and Investigating Complaints to the Right Level?

Kim Trautman – Medical Device, IVD and Combo Product Expert ### 2544312###Moderator###Expert###Medical Device, IVD and Combo Product Expert###
Moderator: Kim Trautman – Medical Device, IVD and Combo Product Expert
### @@@ Monica Wilkins – Abbott ### 2544317###Speaker###VP Regulatory, Quality & Compliance###Abbott###
Speaker: Monica Wilkins – Abbott
### @@@ Aaron Dunbar – Boston Scientific ### 2544307###Speaker###Vice President of Quality Systems & Post Market###Boston Scientific###
Speaker: Aaron Dunbar – Boston Scientific
### @@@ Phil Pontikos – Retired, FDA ### 2544315###Speaker######Retired, FDA###
Speaker: Phil Pontikos – Retired, FDA
###
Breakout #2: Due Diligence – Are You Doing Enough? What About After Acquisition?

Monica Wilkins – Abbott ### 2544317###Moderator###VP Regulatory, Quality & Compliance###Abbott###
Moderator: Monica Wilkins – Abbott
### @@@ Braulio Ortiz – BioTeknica ### 2617842###Speaker###Principal Consultant###BioTeknica###
Speaker: Braulio Ortiz – BioTeknica
### @@@ Dennett Kouri – Edwards Lifesciences ### 2617845###Speaker###Senior Vice President, Corporate Quality, Regulatory and Clinical###Edwards Lifesciences###
Speaker: Dennett Kouri – Edwards Lifesciences
###
Breakout #2: What’s New in CDRH Premarket Programs

Heather Rosecrans – Eliquent Life Sciences | Vice President Regulatory Affairs, MDMA ### 2544311###Moderator###Executive Vice President, Medical Devices & Combination Products###Eliquent Life Sciences | Vice President Regulatory Affairs, MDMA###
Moderator: Heather Rosecrans – Eliquent Life Sciences | Vice President Regulatory Affairs, MDMA
### @@@ Mark Leahey – Medical Device Manufacturers Association (MDMA) ### 2591577###Speaker###President & CEO###Medical Device Manufacturers Association (MDMA)###
Speaker: Mark Leahey – Medical Device Manufacturers Association (MDMA)
### @@@ Dan Schultz – Eliquent Life Sciences ### 2606027###Speaker###Principal, Medical Devices & Combination Products###Eliquent Life Sciences###
Speaker: Dan Schultz – Eliquent Life Sciences
### @@@ Sean Boyd – QualityHub, Inc. ### 2629282###Speaker###Vice President###QualityHub, Inc.###
Speaker: Sean Boyd – QualityHub, Inc.
###
Breakout #3: Addressing 510(k) Review Challenges

Bill Brodbeck – STERIS Corporation ### 2544305###Moderator###Vice President, Regulatory Affairs###STERIS Corporation###
Moderator: Bill Brodbeck – STERIS Corporation
### @@@ Heather Rosecrans – Eliquent Life Sciences | Vice President Regulatory Affairs, MDMA ### 2544311###Moderator###Executive Vice President, Medical Devices & Combination Products###Eliquent Life Sciences | Vice President Regulatory Affairs, MDMA###
Moderator: Heather Rosecrans – Eliquent Life Sciences | Vice President Regulatory Affairs, MDMA
### @@@ Clarence Murray, III – STERIS Corporation ### 2608391###Speaker###Director, Regulatory Affairs###STERIS Corporation###
Speaker: Clarence Murray, III – STERIS Corporation
### @@@ Tony Piotrkowski – STERIS Corporation ### 2591586###Speaker###Director of Regulatory Affairs###STERIS Corporation###
Speaker: Tony Piotrkowski – STERIS Corporation
### @@@ Lisa Griffin Vincent (she/her/hers) – GT Metabolic Solutions, Inc. (virtual) ### 2591603###Speaker###Chief Regulatory, Quality, Clinical Officer###GT Metabolic Solutions, Inc. (virtual)###
Speaker: Lisa Griffin Vincent (she/her/hers) – GT Metabolic Solutions, Inc. (virtual)
### she/her/hers @@@ Liz Claverie-Williams (she/her/hers) – Claverie & Associates Consulting, LLC ### 2630111###Speaker###Principal###Claverie & Associates Consulting, LLC###
Speaker: Liz Claverie-Williams (she/her/hers) – Claverie & Associates Consulting, LLC
### she/her/hers
Breakout #3: Supply Chain Resiliency: Evolving Challenges and Best Practices

Bill Brodbeck – STERIS Corporation ### 2544305###Moderator###Vice President, Regulatory Affairs###STERIS Corporation###
Moderator: Bill Brodbeck – STERIS Corporation
### @@@ Michael Gallucci – Edwards Lifesciences ### 2591572###Speaker###VP Strategic Sourcing###Edwards Lifesciences###
Speaker: Michael Gallucci – Edwards Lifesciences
### @@@ Matt Graf – Cook Medical ### 2591574###Speaker###Corporate Director, Quality Assurance & Global Quality Systems###Cook Medical###
Speaker: Matt Graf – Cook Medical
###
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Close-Out

Kim Belsky – AFDO/RAPS Healthcare Products Collaborative ### 2544306###Speaker###Strategic Facilitator###AFDO/RAPS Healthcare Products Collaborative###
Speaker: Kim Belsky – AFDO/RAPS Healthcare Products Collaborative
###
Conference Close-Out

Kim Belsky – AFDO/RAPS Healthcare Products Collaborative ### 2544306###Speaker###Strategic Facilitator###AFDO/RAPS Healthcare Products Collaborative###
Speaker: Kim Belsky – AFDO/RAPS Healthcare Products Collaborative
###
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Day 2 Close

Kim Belsky – AFDO/RAPS Healthcare Products Collaborative ### 2544306###Speaker###Strategic Facilitator###AFDO/RAPS Healthcare Products Collaborative###
Speaker: Kim Belsky – AFDO/RAPS Healthcare Products Collaborative
###
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FDA Medical Device Inspections

Susan Matthias – FDA (Virtual) ### 2544309###Moderator###Consumer Safety Officer, Special Assistant, Office of Medical Device and Radiological Health Inspectorate (OMDRHI), Medical Products Inspectorate (MPI), Office of Inspections and Investigations (OII)###FDA (Virtual)###
Moderator: Susan Matthias – FDA (Virtual)
### @@@ Phil Pontikos – Retired, FDA ### 2544315###Moderator######Retired, FDA###
Moderator: Phil Pontikos – Retired, FDA
### @@@ Anne Reid – FDA (Virtual) ### 2591589###Speaker###Office Director, Office of Medical Device and Radiological Health Inspectorate (OMDRHI), Medical Products Inspectorate (MPI), Office of Inspections and Investigations (OII)###FDA (Virtual)###
Speaker: Anne Reid – FDA (Virtual)
### @@@ Rhonda Mecl – FDA (Virtual) ### 2591581###Speaker###Deputy Program Director, Office of Medical Device and Radiological Health Inspectorate (OMDRHI), Medical Products Inspectorate (MPI), Office of Inspections and Investigations (OII)###FDA (Virtual)###
Speaker: Rhonda Mecl – FDA (Virtual)
###
FDA’s QMSR Implementation Status

Phil Pontikos – Retired, FDA ### 2544315###Moderator######Retired, FDA###
Moderator: Phil Pontikos – Retired, FDA
### @@@ Keisha Thomas, MS, MHS, CQA, RAC – FDA (Virtual) ### 2591601###Speaker###Associate Director for Compliance & Quality, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH)###FDA (Virtual)###
Speaker: Keisha Thomas, MS, MHS, CQA, RAC – FDA (Virtual)
### @@@ Karen Masley-Joseph – FDA (Virtual) ### 2591579###Speaker###Senior Advisor, Office of Medical Device and Radiological Health Inspectorate (OMDRHI), Medical Products Inspectorate (MPI), Office of Inspections and Investigations (OII)###FDA (Virtual)###
Speaker: Karen Masley-Joseph – FDA (Virtual)
###
Fireside Chat with Industry Leaders

Jessica Zeller – Edwards Lifesciences ### 2562430###Moderator###Vice President, Quality, & Regulatory Counsel,###Edwards Lifesciences###
Moderator: Jessica Zeller – Edwards Lifesciences
### @@@ Bill Brodbeck – STERIS Corporation ### 2544305###Speaker###Vice President, Regulatory Affairs###STERIS Corporation###
Speaker: Bill Brodbeck – STERIS Corporation
### @@@ Aaron Dunbar – Boston Scientific ### 2544307###Speaker###Vice President of Quality Systems & Post Market###Boston Scientific###
Speaker: Aaron Dunbar – Boston Scientific
### @@@ Shannon Hoste – Pathway for Patient Health ### 2544316###Speaker###Chief Scientific Officer###Pathway for Patient Health###
Speaker: Shannon Hoste – Pathway for Patient Health
###
Fostering Medical Device Improvement: FDA’s Voluntary Improvement Program

Aaron Dunbar – Boston Scientific ### 2544307###Moderator###Vice President of Quality Systems & Post Market###Boston Scientific###
Moderator: Aaron Dunbar – Boston Scientific
### @@@ Kim Kaplan – ISACA ### 2616090###Speaker###Senior Product Manager###ISACA###
Speaker: Kim Kaplan – ISACA
### @@@ Erin Keith (she/her/hers) – FDA (Virtual) ### 2591576###Speaker###Materials Engineer, Compliance and Quality Program, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH)###FDA (Virtual)###
Speaker: Erin Keith (she/her/hers) – FDA (Virtual)
### she/her/hers @@@ Roseanne Leaupepe – Fisher & Paykel Healthcare ### 2633413###Speaker###General Manager – Quality Systems###Fisher & Paykel Healthcare###
Speaker: Roseanne Leaupepe – Fisher & Paykel Healthcare
### @@@ Keisha Thomas, MS, MHS, CQA, RAC – FDA (Virtual) ### 2591601###Speaker###Associate Director for Compliance & Quality, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH)###FDA (Virtual)###
Speaker: Keisha Thomas, MS, MHS, CQA, RAC – FDA (Virtual)
###
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Global Shift in Clinical Expectations

Aaron Dunbar – Boston Scientific ### 2544307###Moderator###Vice President of Quality Systems & Post Market###Boston Scientific###
Moderator: Aaron Dunbar – Boston Scientific
### @@@ Gert Bos – Qserve Group ### 2544966###Moderator###Executive Director & Partner###Qserve Group###
Moderator: Gert Bos – Qserve Group
### @@@ Mindy McCann – Qserve Group ### 2591580###Speaker###Vice President US Operations and Principal Consultant###Qserve Group###
Speaker: Mindy McCann – Qserve Group
### @@@ Matt Albert – Boston Scientific ### 2591565###Speaker###Senior Fellow, Corporate Clinical Quality###Boston Scientific###
Speaker: Matt Albert – Boston Scientific
### @@@ Andrew Webster – Zimmer Biomet ### 2638792###Speaker###Senior Manager, Post Market Surveillance Team###Zimmer Biomet###
Speaker: Andrew Webster – Zimmer Biomet
###
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Investigator Insights

Monica Wilkins – Abbott ### 2544317###Moderator###VP Regulatory, Quality & Compliance###Abbott###
Moderator: Monica Wilkins – Abbott
### @@@ Laureen Geniusz – FDA (Virtual) ### 2591573###Speaker###Consumer Safety Officer, Office of Medical Device and Radiological Health Inspectorate (OMDRHI), Medical Products Inspectorate (MPI), Office of Inspections and Investigations (OII)###FDA (Virtual)###
Speaker: Laureen Geniusz – FDA (Virtual)
### @@@ Susan Matthias – FDA (Virtual) ### 2544309###Speaker###Consumer Safety Officer, Special Assistant, Office of Medical Device and Radiological Health Inspectorate (OMDRHI), Medical Products Inspectorate (MPI), Office of Inspections and Investigations (OII)###FDA (Virtual)###
Speaker: Susan Matthias – FDA (Virtual)
### @@@ CDR Tom Peter – FDA (Virtual) ### 2628740###Speaker###Senior Operations Officer, Office of Medical Device and Radiological Health Inspectorate (OMDRHI), Office of Inspections and Investigations (OII)###FDA (Virtual)###
Speaker: CDR Tom Peter – FDA (Virtual)
### @@@ Katelyn Staub-Zamperini – FDA (Virtual) ### 2628742###Speaker###Medical Device Senior Operations Officer, Office of Medical Device and Radiological Health Inspectorate (OMDRHI), Office of Inspections and Investigations (OII)###FDA (Virtual)###
Speaker: Katelyn Staub-Zamperini – FDA (Virtual)
### @@@ LCDR Mary Millner – FDA (Virtual) ### 2629266###Speaker###Senior Operations Officer, Office of Medical Device and Radiological Health Inspectorate (OMDRHI), Office of Inspections and Investigations (OII)###FDA (Virtual)###
Speaker: LCDR Mary Millner – FDA (Virtual)
###
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Let's Make a Difference!

Kim Belsky – AFDO/RAPS Healthcare Products Collaborative ### 2544306###Speaker###Strategic Facilitator###AFDO/RAPS Healthcare Products Collaborative###
Speaker: Kim Belsky – AFDO/RAPS Healthcare Products Collaborative
### @@@ Steven Mandernach – Association of Food and Drug Officials (AFDO) ### 2482795###Speaker###Executive Director###Association of Food and Drug Officials (AFDO)###
Speaker: Steven Mandernach – Association of Food and Drug Officials (AFDO)
### @@@ Bill McMoil – Regulatory Affairs Professionals Society, RAPS (Welcome) ### 2622220###Speaker###Executive Director###Regulatory Affairs Professionals Society, RAPS (Welcome)###
Speaker: Bill McMoil – Regulatory Affairs Professionals Society, RAPS (Welcome)
###
LUNCH
LUNCH
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MedCon Annual Dinner - Ticketed Event
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Networking Reception
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Opening Day 2

Kim Belsky – AFDO/RAPS Healthcare Products Collaborative ### 2544306###Speaker###Strategic Facilitator###AFDO/RAPS Healthcare Products Collaborative###
Speaker: Kim Belsky – AFDO/RAPS Healthcare Products Collaborative
###
Opening Day 3

Kim Belsky – AFDO/RAPS Healthcare Products Collaborative ### 2544306###Speaker###Strategic Facilitator###AFDO/RAPS Healthcare Products Collaborative###
Speaker: Kim Belsky – AFDO/RAPS Healthcare Products Collaborative
###
Opening Reception
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Patient Experience Plenary #1

Aaron Dunbar – Boston Scientific ### 2544307###Moderator###Vice President of Quality Systems & Post Market###Boston Scientific###
Moderator: Aaron Dunbar – Boston Scientific
### @@@ John Sperzel, III – T2 Biosystems, Inc. ### 2591594###Speaker###Chairman and CEO###T2 Biosystems, Inc.###
Speaker: John Sperzel, III – T2 Biosystems, Inc.
###
Patient Experience #2 Exploring Patient Experience

Shannon Hoste – Pathway for Patient Health ### 2544316###Moderator###Chief Scientific Officer###Pathway for Patient Health###
Moderator: Shannon Hoste – Pathway for Patient Health
### @@@ Lane Berlin – Grandview Heights Division of Fire ### 2591606###Speaker###Captain###Grandview Heights Division of Fire###
Speaker: Lane Berlin – Grandview Heights Division of Fire
###
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Registration
Registration
Registration
Risk Management - Systems Perspective

Shannon Hoste – Pathway for Patient Health ### 2544316###Moderator###Chief Scientific Officer###Pathway for Patient Health###
Moderator: Shannon Hoste – Pathway for Patient Health
### @@@ Kim Trautman – Medical Device, IVD and Combo Product Expert ### 2544312###Moderator###Expert###Medical Device, IVD and Combo Product Expert###
Moderator: Kim Trautman – Medical Device, IVD and Combo Product Expert
### @@@ Bill Brodbeck – STERIS Corporation ### 2544305###Moderator###Vice President, Regulatory Affairs###STERIS Corporation###
Moderator: Bill Brodbeck – STERIS Corporation
### @@@ Brian Siroka (he/him/his) – MEDIcept ### 2591591###Speaker###Associate Medical Device Consultant###MEDIcept###
Speaker: Brian Siroka (he/him/his) – MEDIcept
### he/him/his @@@ Evan Markley – Eli Lilly and Company ### 2591578###Speaker###Risk Management Engineer###Eli Lilly and Company###
Speaker: Evan Markley – Eli Lilly and Company
### @@@ David Murray – Illumina ### 2617827###Speaker###Senior Director, Quality###Illumina###
Speaker: David Murray – Illumina
###
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The Device Design Change Life Cycle Experience

Bill Brodbeck – STERIS Corporation ### 2544305###Moderator###Vice President, Regulatory Affairs###STERIS Corporation###
Moderator: Bill Brodbeck – STERIS Corporation
### @@@ David Elder (he/him/his) – Eliquent Life Sciences ### 2591568###Speaker###Principal, Quality & Compliance###Eliquent Life Sciences###
Speaker: David Elder (he/him/his) – Eliquent Life Sciences
### he/him/his @@@ Eric Henry – King & Spalding LLP ### 2482790###Moderator###Senior Quality & Regulatory Compliance Advisor, FDA & Life Sciences Practice###King & Spalding LLP###
Moderator: Eric Henry – King & Spalding LLP
### @@@ Evan Markley – Eli Lilly and Company ### 2591578###Speaker###Risk Management Engineer###Eli Lilly and Company###
Speaker: Evan Markley – Eli Lilly and Company
### @@@ Chitra Nadig – KeborMed ### 2591582###Speaker###Director of Quality and Regulatory###KeborMed###
Speaker: Chitra Nadig – KeborMed
### @@@ Tony Piotrkowski – STERIS Corporation ### 2591586###Speaker###Director of Regulatory Affairs###STERIS Corporation###
Speaker: Tony Piotrkowski – STERIS Corporation
### @@@ Phil Pontikos – Retired, FDA ### 2544315###Speaker######Retired, FDA###
Speaker: Phil Pontikos – Retired, FDA
### @@@ Heather Rosecrans – Eliquent Life Sciences | Vice President Regulatory Affairs, MDMA ### 2544311###Speaker###Executive Vice President, Medical Devices & Combination Products###Eliquent Life Sciences | Vice President Regulatory Affairs, MDMA###
Speaker: Heather Rosecrans – Eliquent Life Sciences | Vice President Regulatory Affairs, MDMA
###
The Solutions Exchange – Culture of Quality

John Krug – Eli Lilly and Company ### 2562427###Moderator###Executive Director and Site Quality Leader of Indianapolis Device Manufacturing###Eli Lilly and Company###
Moderator: John Krug – Eli Lilly and Company
### @@@ Kim Trautman – Medical Device, IVD and Combo Product Expert ### 2544312###Moderator###Expert###Medical Device, IVD and Combo Product Expert###
Moderator: Kim Trautman – Medical Device, IVD and Combo Product Expert
### @@@ Jessica Zeller – Edwards Lifesciences ### 2562430###Moderator###Vice President, Quality, & Regulatory Counsel,###Edwards Lifesciences###
Moderator: Jessica Zeller – Edwards Lifesciences
###