Name
Session 1: Reliance in a Premarket Setting
Date & Time
Monday, March 11, 2024, 10:05 AM - 12:20 PM
Tracey Duffy Nada Alkhayat Mario Cesar Muniz Ferrer Tammy Steuerwald Naoki MOROOKA Chloe Spathari Maurizio Andreano Maria Pombo-Castro
Description

Case studies in premarket reliance implementation 

  • Tracey Duffy, First Assistant Secretary, Medical Devices and Product Quality Division, TGA Australia
  • Woei Jiuang Wong, Asst Group Director, HSA Singapore
  • Maria Luz Pombo-Castro, Unit Chief, for Quality and Regulations of Medicines and Health Technologies (IMT/QR), PAHO
  • Nada Alkhayat, Policy Officer, European Commission
  • Naomi Morioka, General Manager of Medication Regulatory Policy Department, Shimadzu Corporation
  • Mario Cesar Muñiz Ferrer, Head of Medical Devices Department, CECMED
  • Tammy Steuerwald, Global Head of Regulatory Policy, Foundational Principles of Supranational Organizations, Roche Diagnostics

10:05 AM-11:35 AM 

Panel Discussion

  • Chloe Spathari, Policy Officer, European Commission
  • Maurizio Andreano, Senior Director - Head of Technical Regulations & Standardization, Siemens Healthineers

11:35 AM-12:20 PM 

Location Name
Amphitheater
Full Address
Ronald Reagan Building & International Trade Center
1300 PENNSYLVANIA AVENUE NW
Washington, DC 20004
United States
Session Type
General Session