SPEAKERS

Jeff Shuren
Jeff Shuren
Director, CDRH
U.S. FDA
Dr. Robert Califf
Dr. Robert Califf
Commissioner of Food and Drugs
U.S. FDA
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Masaaki Ohtsuka
Secretary General
JIRA
Jesus Rueda Rodriguez
Jesus Rueda Rodriguez
Director General International Affairs
MedTech Europe
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Diane Wurzburger
VP Regulatory Affairs, Quality & Global Policy
GE Healthcare
Kuniki Imagawa
Kuniki Imagawa
Deputy Division Director
PMDA Japan
Hiiti Sillo
Hiiti Sillo
Unit Head, Regulation and Safety
WHO
Tracey Duffy
Tracey Duffy
First Assistant Secretary
TGA Australia
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Woei Jiuang Wong
Asst Group Director
HSA Singapore
Nada Alkhayat
Nada Alkhayat
Policy Officer
European Commission
Mario Cesar Muñiz Ferrer
Mario Cesar Muñiz Ferrer
Head of Medical Devices Department
CECMED
Maria Pombo-Castro
Maria Pombo-Castro
Unit Chief, Quality & Regulation Medicines & Health Tech
PAHO
Tammy Steuerwald
Tammy Steuerwald
Global Head of Regulatory Policy, Foundational Principles & Supranational Organizations
Roche Diagnostics
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Naoki MOROOKA
Senior General Manager of Medical Regulatory Policy
Shimadzu Corporation
Chloe Spathari
Chloe Spathari
Policy Officer
European Commission
Maurizio Andreano
Maurizio Andreano
Sen. Director Technical Regulations & Standardization
Siemens Healthineers
Ana Carolina Moreira Marino Araujo
Ana Carolina Moreira Marino Araujo
Senior Advisor
ANVISA Brazil
Mariela Aranda
Mariela Aranda
Head of IVD Departament
ANMAT Argentina
Anat Boehm-Cagan
Anat Boehm-Cagan
Head of Regulatory Strategy and Partnerships
MTIIR Israel
Ching-Wei Chang
Ching-Wei Chang
Section Chief
Taiwan Food and Drug Administration
Philippe Auclair
Philippe Auclair
Senior Director RA strategy
Abbott
Leo Hovestadt
Leo Hovestadt
Director Governmental Affairs EU
Elekta
Sally Prawdzik
Sally Prawdzik
Acting Director, Policy and International Programs
Health Canada
Philip Brown
Philip Brown
Director, Regulatory and Compliance
ABHI
Augusto Geyer
Augusto Geyer
General Manager, Office of Medical Devices
ANVISA
Markus Wälti
Markus Wälti
Head of Division Medical Devices Vigilance
Swissmedic
Maria Cecilia Lopez Gutierrez
Maria Cecilia Lopez Gutierrez
Head of Medical Devices Registration Office
ISP, Chile
Paulyne Wairimu
Paulyne Wairimu
Head of Medical Devices & IVDs
Pharmacy & Poisons Board, Kenya
Nicole Taylor Smith
Nicole Taylor Smith
Vice President, Head of Regulatory Science & Policy
Philips
Fatemeh Razjouyan
Fatemeh Razjouyan
Director, Regulatory Policy, International and Harmonization
Medtronic
Mark Abdoo
Mark Abdoo
Associate Commissioner for Global Policy and Strategy
U.S. FDA
Bruce Randall
Bruce Randall
Director General
Medical Devices Directorate, Health Canada
Tomoyuki Miyasaka
Tomoyuki Miyasaka
Deputy Director
NHLW
Alvin LEE
Alvin LEE
Deputy Director (Analytics and Capability Building)
Ministry of Health, Singapore
Ahram Cho
Ahram Cho
Deputy Director
MFDS
Laura Squire
Laura Squire
Chief Healthcare Quality and Access Officer
MHRA
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Melissa Torres
Associate Director for International Affairs
U.S. FDA
André Breisinger
André Breisinger
Medical Devices Regulation Expert
Swissmedic
Irena Prat
Irena Prat
Team Lead
World Health Organization
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MiRa Jacobs
Division Director, Division of Digital Health Policy
U.S. FDA
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Daniel Yoon
Regulatory Advisor
Health Canada
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Michelle Noonan
International Policy Analyst
U.S. FDA
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Ana Patricia Pineda
International Regulatory Analyst
U.S. FDA
ALEXANDRE LEMGRUBER
ALEXANDRE LEMGRUBER
Unit Chief a.i., Access to medicines and health technologies
PAHO
Neil Mafnas
Neil Mafnas
Senior Project Management Officer
U.S. FDA
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CHIDAE PARK
RA Managing Director
Lutronic Corporation
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Raina Dauria
VP, Global Regulatory Policy, MedTech
Johnson & Johnson
Olga van Grol-Lawlor
Olga van Grol-Lawlor
Senior Global Regulatory Intelligence & Advocacy Manager
Boston Scientific
Rumi Young
Rumi Young
Director, Regulatory Policy
Becton Dickinson
Greg LeBlanc
Greg LeBlanc
Director, Regulatory Affairs and Quality Systems
Cook Medical
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Yuan Peng
director of medical device registration 1 division
NMPA
Elaine Grimes
Elaine Grimes
Devices Regulatory Specialist
MHRA