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Global Harmonization of Medical Device Regulations Symposium

Agenda - Wednesday, Nov. 9, 2016

 

7:00 am Registration, Networking & Continental Breakfast

7:45 am

Welcome & Introduction

Arthur Erdman, PhD, Director > Medical Devices Center
Susan Alpert, PhD, MD, Principle > SFA Consulting

8:00 am

FDA Perspectives on Global Harmonization

Discussion Leaders >
Melissa Torres, International Affairs > FDA CDRH Global Harmonization (via web)
Susan Alpert, PhD, MD, Principle > SFA Consulting

8:30 am

Industry Experiences, Barriers & Suggestions for Global Collaborations

Keynote >
Randy Schiestl, Vice President, Research & Development, Global Technology > Boston Scientific

8:50 am

Panel follow-up discussions on Regulatory Harmonization

Discussion Leaders >
Susan Alpert, PhD, MD, Principle > SFA Consulting
Lisa Becker, Senior Director of Regulatory Affairs > St. Jude Medical
Bill Betten, Director Business Solutions > Devicix
Randy Schiestl, Vice President, Research & Development, Global Technology > Boston Scientific Corporation
Melissa Torres, International Affairs > FDA CDRH Global Harmonization (via web)

9:30 am

Break and Networking

10:00 am

Role of Computational Modeling to Accelerate/Reduce Regulatory Pathways

Discussion Leaders >
Tina Morrison, PhD, FDA Deputy Director > FDA CDRH Modeling/Simulation (via web)
Dawn Bardot, PhD, Vice President, Technology Innovation > Medical Device Innovation Consortium

10:50 am

Potential Role of Emerging Technologies, such as 3D Printing, for Simplifying Regulatory Processes

Discussion Leaders >
Derek Mathers, Director, Advanced Applications Development > Worrell
Lt. James Coburn, MSc, Sr Research Engineering Officer > FDA CDRH Additive Manufacturing Group (via web)
Matthew Di Prima, PhD, Materials Scientist > FDA CDRH Additive Manufacturing Group (via web)

11:15 am

Global Harmonization Key Topics

Discussion Leaders >
Susan Alpert, PhD, MD, Principle > SFA Consulting
Cristin Moran, Front End Innovation Lead > 3M Health Care
Ken Merdan, Senior R&D Fellow, Global Technology > Boston Scientific Corporation

> benefit patients worldwide and improve disease control
> help solve unmet needs globally for improvement healthcare outcomes
> include safety and efficacy concerns
> recognize varying medical needs across the globe
> address cost and profit models
> discuss how to cooperate around the use of computational models
> discuss standards/regulations around custom/patient specific 3D printed devices
> recognize differences in regulatory climates
> recognize manufacturing and distribution concerns
> discuss compliance issues
> discuss strategy about the role of public/privateb partnerships

12:00 pm

Program Review & Creation of Actionable Steps toward Global Harmonization Goals
continuing in April 2017

12:30 pm Adjourn

 

Special Event Conveners:

Devicix FDAMAAMDICWorrell


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