Click here to go to the previous page
Asian Regulatory Agencies Relocated into Biotech Science Park as a Strategy for Global Drug Development
Program Code:
304
Date:
Wednesday, June 27, 2012
Time:
8:00 AM to 9:30 AM
EST
CHAIR
(S):
Center for Drug Evaluation support Taiwan FDA in tech. review of IND/NDA/HTA for. Dr. Chern plays an active role in promoting ICH concept, GCP education, good review practice, bridging study, new drug development, Health Technology Assessment and regulatory convergency in Asia.
|
Dr. Romi Singh has extensive scientific and management experience in top-tier biopharmaceutical companies. His experience spans across drug development—drug discovery to commercialization. He is recognized as an expert on international regulatory affairs, clinical trials and drug registrations.
|
PRESENTER
(S):
Ling-Mei Wang, Industrial Technology Research Institute, Taiwan
Tsuyoshi Ando,
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
I obtained Ph.D. degree in Pharmacology from Tokyo University of Pharmacy and Life Science in 2003. I joined the PMDEC, the National Institute of Health Sciences in 2003. I am currently reviewer of the Office of Biologics?in the PMDA and also join ICH-Q11 as deputy topic leader.
|
Dr. Romi Singh has extensive scientific and management experience in top-tier biopharmaceutical companies. His experience spans across drug development—drug discovery to commercialization. He is recognized as an expert on international regulatory affairs, clinical trials and drug registrations.
|
Description
Asian regulatory agencies, like the Singapore Health Sciences Authority and the Korea FDA, were relocated into biotech science parks, and Taiwan has developed a strategy of a supra-incubator center to become a proactive supporter of global drug development. In this session, we will examine these strategies and outcomes of new drug development from Singapore, Korea, and Taiwan.
Learning Objectives:
Describe the supra-incubation center in Taiwan as a strategic infrastructure for global drug development
Appraise the benefit of regulatory agencies inside biotech science parks in Korea and Singapore
Identify regulatory science as a critical factor for global drug development.