第11回DIAアジア新薬カンファレンス

With the economic growth and development of the regulatory system in The Association of Southeast Asian Nations (ASEAN) region, there has been more and more focus on conducting clinical trials in the region. Although there are certain regulatory challenges, ASEAN has shown many benefits to clinical trial conduct such as lower cost, ease of access to a variety of populations, a big treatment-naïve patient pool, etc. However, in order to fully realize successful development in this region, we must better understand the regulatory environment and prepare good strategies to overcome these regulatory challenges. In this session, a speaker from HSA in Singapore will share their perspective on the regulatory environment from the agency perspective, and a speaker from industry will share their regulatory experience from that perspective. This balanced overview will be helpful for strategic decision making on clinical trial initiatives in the ASEAN region.