This course specifically focuses on the regulatory compliance requirements and procedures for conducting Clinical Trials on Pharmaceutical Products in Japan. The course will also cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in South Korea. Content will also include descriptions of the methods by which regulators in the Ministry of Health / KFDA process filings and registrations for new Clinical Studies and what is expected throughout the lifecycle of Phase I – Phase IV studies in the country.

Learning Objectives:

This course is designed to provide a detailed overview of the regulatory requirements, local challenges and important cultural aspects of working with The Ministry of Health, the KFDA and Institutional IRBs in organizing and implementing Clinical Trials in South Korea. It will provide training on:

• The Regulatory Structure in South Korea.
• Understanding the South Korean Drug Development Process for Pharmaceuticals.
• How to begin your company's involvement in South Korea: local licenses, personnel and facilities required.
• South Korean Healthcare System and Reimbursement.
• Clinical Trials: Why South Korea? KFDA's requirements, the Application Process, CRO Selection and Start-up.
• The current key regulations effecting Investigational Medicinal Products and Requirements for Clinical Trials in South Korea.
• Understanding the local concerns and specific challenges in working with Korean Regulatory Personnel.
• Understanding the Local Culture: Realistic expectations, timing on reviews, effective strategies for adding.
• Korea to your company's global market presence.