亞太藥品優良審查準則研討會(APEC Good Review Practice Workshop on Pharmaceuticals)

On behalf of the Workshop Organizing Committee and Food and Drug Administration of Chinese Taipei, I am pleased to invite you to join the upcoming 2010 "APEC Good Regulatory Practice Workshop on Pharmaceuticals". The main topic of discussion for this workshop is "Good Review Practices: A Key Enabler in Promoting Quality Decision-making".  It will be held at the Evergreen Fundation International Convention Center in Taipei from November 3 to 6, 2010. The goal of the workshop is to initiate and facilitate dialogue on the topic of good review practices for pharmaceuticals.  This workshop is one of the major harmonization efforts of APEC Life Science Innovation Forum (LSIF).  Your participation will certainly be among the highlights of the workshop. We sincerely hope you can reserve your schedule for this exciting meeting and wish all of you having a wonderful time in Taipei.

Sincerely yours,
 

Jaw-Jou Kang, Ph. D.
Director General
Food and Drug Administration
Department of Health
Chinese, Taipei. 

 

APEC Good Review Practice Workshop on Pharmaceuticals Preliminary Program  11/3 (Wednesday)

Time	Subjects		Moderators /Speakers /Panelists
09:30–10:00		Registration
09:30–10:00		Networking
10:00–10:10	Opening Remarks		Dr. Jaw-Jou Kang Director-General Food and Drug Administration, Department of Health, Chinese Taipei
10:10–10:25	Group Photo		All Speakers and Moderators and VIP
Session A Keynote Speech		Moderator: Dr. Jaw-Jou Kang Director-General Food and Drug Administration, Department of Health, Chinese Taipei
10:25–10:55	Promotion of an effective approach to harmonization and cooperation with good review practice		Mr. Mike Ward APEC LSIF RHSC Chairman, Health Canada
Session B-1 GRP Fundamentals Fundamentals of Good Review Practice-Perspectives from Regulators and Industry on Critical Thinking behind Regulations, Procedures, Templates, and Communication with Stakeholders		Moderators: Mr. Mike Ward APEC LSIF RHSC Chairman, Health Canada
10:55–11:35	Quality Measures for the review process: How these underpin Good Review Practice		Dr. Neil McAuslane Director CMR International Institute for Regulatory Science United Kingdom
11:35–12:15	Pilot study of APEC PER Scheme in the GRP workshop from Taiwan		Dr. Herng-Der Chern Executive Director Center for Drug Evaluation Chinese Taipei
12:15–12:55	Thoughts about Good Regulatory Practices from An Ex-FDAer in Industry		Dr. Florence Houn FDAAA/Celegene Vice President Regulatory Policy and Strategy, Celgene Corporation United States
12:50–14:00		Lunch Break
Session B-2 Competence Building Points to Consider -Training and nurturing of regulators -Utilization of review templates and other tools -Qualification and certification of regulators		Moderators: Dr. Oliver Hu Distinguished Professor National Defense Medical Center, Chinese Taipei
14:00–14:40		Dr. Meir-Chyun Tzou Director Division of Drug and New Biotechnology Products, Food and Drug Administration,