Session Information
2008 BIO International Convention
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Regulatory Challenges and Solutions in Asia-Pacific
Track
:
Regulatory
Program Code:
911
Date:
Thursday, June 19, 2008
Time:
10:30 AM to 12:00 PM
EST
Location:
30DE
CHAIR
:
Chris Halloway, PhD, BSc, Director of Regulatory Affairs & CSO, ERA Consulting Group
SPEAKER
(S):
Leonie Hunt, MBA, MBBS, Director Drug Safety and Evaluation Branch , Therapeutic Goods Administration (TGA)
Stewart Jessamine, Medsafe, the New Zealand Medicines and Medical Devices Safety Authority
Chih-Hwa Wallace Lin, PhD, Director, Division of Resource Development, Center for Drug Evaluation, Taiwan Takahisa Murakami, BA, Associate Executive Director Center for Product Evaluation, PMDA, Pharmaceuticals and Medical Devices Agency (PMDA)
Description
This session will address how the regulatory agencies in Korea, Taiwan and Japan have responded to the biopharmaceutical industry's interest in expanding the number of clinical trials in the Asia-Pacific region and how these changes are viewed by other agencies such as the Australian TGA. In addition, the panel will discuss the regulators' point of view regarding the acceptability of foreign clinical data from trials involving biotech compounds.
Objective1:"Discuss the current regulatory approval processes and relevant issues concerning the conduct of clinical trials and the NDA approval process with a focus on biotech compounds."
Objective2:Discuss the acceptability of foreign clinical data by Japanese, Taiwanese and Korean regulators.
Objective3:Compare and contrast the regulatory developments in Japan, Korea and Taiwan with those of the FDA , the EMEA and the Australian TGA for biotech compounds.
Objective1:"Discuss the current regulatory approval processes and relevant issues concerning the conduct of clinical trials and the NDA approval process with a focus on biotech compounds."
Objective2:Discuss the acceptability of foreign clinical data by Japanese, Taiwanese and Korean regulators.
Objective3:Compare and contrast the regulatory developments in Japan, Korea and Taiwan with those of the FDA , the EMEA and the Australian TGA for biotech compounds.
Streaming Audio with
PowerPoint Slides
PowerPoint Slides
(Code: 911)
This session is a part of: