South Korea: Navigating the Clinical Trial and Regulatory Environment

Overview: 

This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceutical Products in South Korea.  The course will 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 corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products.

Learning Objectives: 

This course is designed to provide an overview of the regulatory environment in South Korea and will provide training in:

• What is the Regulatory Structure in South Korea
• Understanding the specific procedures for Pharmaceutical Products
• How to begin your company involvement in South Korea
• Requirements for Clinical Trials in South Korea
• South Korean Drug Development Process
• The Changing KFDA
• Understanding the Local Culture: How to negotiate with the regulators

Who will benefit: 

This course will be of benefit to regulatory personnel whose responsibilities require knowledge of South Korea's regulatory environment.  Administrative staff responsible for ensuring compliance with regulatory filings and overall regulatory compliance requirements will also find this training highly relevant.  Any sales or general management employee requiring an understanding of how regulations and compliance issues impact the organization will also benefit.