Contents：

主講人：蕭金福博士(國家衛生研究院群體健康科學研究所研究員)

摘要Abstract:
Recently, global drug development has attracted much attention from pharmaceutical companies and regulatory agencies. The ICH E5 guideline defines a bridging study as a supplementary study conducted in the new region to allow extrapolation of the foreign clinical data to the population of the new region. In Taiwan, the Center of Drug Evaluation has successfully developed a sponsor self-evaluation check-list, a decision-making tree, and consultation procedure. Requirement of bridging evaluation was formally announced on January 1, 2004. Unlike traditional clinical trials, the design of multiregional clinical trial (MRCT) recruiting subjects from many countries around the world under the same protocol has led to a new strategy for drug development. This kind of design has been widely adopted by global pharmaceutical companies, which seek simultaneous drug development, submission, and regulatory approval throughout key world markets to hasten the market availability of the drug. From the beginning of 21st century, the trend for simultaneous clinical development in Taiwan being undertaken simultaneously with clinical trials conducted in Europe and the United States has been speedily rising. In this presentation, we will give an overview on how Taiwan gets involved in the global drug developments including local clinical trials, bridging evaluations, and multiregional clinical trials.

Time：

2022/03/29 14:10 ~ 2022/03/29 16:00

Registration period：

2022/03/17 16:30 ~ 2022/03/28 17:00

Location：

科學館 S433室