Name
Session 1: Enabling Conditions for Effective Regulation of Medical Devices
Date & Time
Monday, September 16, 2024, 11:00 AM - 12:30 PM
Speakers
Mr. Duglas Rodriguez Calderon, Global Head of LATAM Regulatory Policy, Roche
Augusto Geyer, Regulatory Specialist, Office of Medical Devices, ANVISA
Mr. Naoki MOROOKA, Senior General Manager of Medical Regulatory Policy, Shimadzu Corporation
Sally Prawdzik, Acting Director, Policy and International Programs, Health Canada
Ms. Sunny Woo, Team Leader, Korea Medical Devices Industry Association(KMDIA), South Korea
Ms. Maria Cecilia Lopez Gutierrez, Head of Medical Devices Registration Office, ISP, Chile
Dr. Shang-Ching Lin, Associate Researcher, Taiwan Food and Drug Administration (TFDA)
Ms. Chadaporn Tanakasemsub, Head of APAC Regulatory Affairs, Johnson & Johnson Medtech
Mr. Maurizio Andreano, Sen. Director Technical Regulations & Standardization, Siemens Healthineers AG
Duglas Rodriguez Calderon Augusto Geyer Naoki MOROOKA Sally Prawdzik Sunny Woo Maria Cecilia Lopez Gutierrez Shang-Ching Lin Chadaporn Tanakasemsub Maurizio Andreano
Description

Overview of enabling conditions

  • Augusto Geyer, Regulatory Specialist; ANVISA

11:00 AM-11:15 AM 

Panel Discussion

  • Augusto Geyer, Regulatory Specialist; ANVISA
  • María Cecilia López, Head of Medical Devices Registration Office; Public Health Institute of Chile (ISP)
  • Fikru D. Bulto, Regulatory Specialist; Ethiopian Food and Drug Administration (EFDA)
  • Shang-Ching Lin, Associate Researcher; Taiwan Food and Drug Administration (TFDA) 
  • Miang Tanakasemsub, Regional Regulatory Affairs head APJ Vision, Johnson & Johnson Medtech, GHWP TC Vice Chair & APACMED RA committee Chair
  • Sunny Woo, Team Leader, International Affairs Team; Korea Medical Devices Industry Association (KMDIA)
  • Duglas Calderon, Global Head of LATAM Regulatory Policy. Global Regulatory Policy and Intelligence; Roche Diagnostics
  • Sally Prawdzik, Acting Director, Policy and International Programs, Medical Devices Directorate, Health Canada 
  • Maurizio Andreano, Sen. Director Technical Regulations & Standardization; Siemens Healthineers

11:15 AM-12:30 PM
Location Name
Grand Pacific Ballroom
Full Address
Seattle Marriott Waterfront
2100 Alaskan Way
Seattle, WA 98121
United States
Session Type
General Session