DIA 48th Annual Meeting
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Current Advancement of Regulatory Reform for Medical Devices in Asia Pacific and Its Strategic Impact
Track
:
Track 09: Medical Diagnostics and Devices
Program Code:
339
Date:
Wednesday, June 27, 2012
Time:
10:00 AM to 11:30 AM
EST
CHAIR
:
Chih-Hwa Wallace Lin, Center for Drug Evaluation, Taiwan
PRESENTER
(S):
Mike Ward, Health Canada, Canada Alan Touch, INC Research, LLC, United States Hsien-Yi Lin, Food and Drug Administration, Department of Health, Taiwan
Description
The symposium will discuss the current advancement of regulatory pathway, the reform of related regulations, and the impact on industry. The harmonization effort initiated by Global Harmonization Task Force (GHTF), Asian Harmonization Working Party (AHWP), and the Regional Harmonization Steering Committee of APEC Life Science Forum will be discussed. Experience will be shared from industrial and regulatory perspectives.
Learning Objectives:
Define the current Asian regulatory reform initiated by GHTF, AHWP and APEC
Describe the current regulatory pathway for medical deceive in Asia Pacific
Discuss strategic approaches for conducting clinical trials for medical devices in Asia Pacific.
Learning Objectives:
Define the current Asian regulatory reform initiated by GHTF, AHWP and APEC
Describe the current regulatory pathway for medical deceive in Asia Pacific
Discuss strategic approaches for conducting clinical trials for medical devices in Asia Pacific.
This session is a part of:
Handout Online
