Accelerate to Market: Regulatory Keys to Clinical Trial Success in Korea & Japan

ACDM members and non-members who would like to join an open discussion concerning a Hot Topic in Data Management.

As APAC region continues to emerge as a pivotal hub for global clinical development, understanding the complex and diverse regulatory landscapes across individual countries is critical for successful trial execution.

This presentation provides a comprehensive overview of regulatory requirements and operational considerations for conducting clinical trials especially in South Korea and Japan. Through comparative analysis and regional insights, we will explore key regulatory timelines, recent policy updates, submission pathways, and local authority expectations, etc. Additionally, country-specific strategies will be discussed to optimize regulatory compliance, reduce start-up delays, and enhance overall trial efficiency.

This session is particularly relevant for Biotech and pharmaceutical companies aiming to expand into APAC to accelerate their global product development and market launch, offering insights into a tailored strategic approach.