3-hr Virtual Seminar: South Korea - Navigating the South Korean Regulatory Compliance and Clinical Trial Environment

Why Should You Attend:

This 3-hr session will help you gain a understanding of the regulatory structure, clinical trial requirements and the conduct of running clinical research in South Korea. It will prepare you for the regulatory approval processes, Agency meetings, the complexities of running studies in South Korea, the importance of partner selection and the cultural knowledge needed for success. The recent changes made by KFDA to be more sponsor-friendly will be reviewed. Real world experiences on actual interactions with the Agency since the changes, will also be discussed.

Note: A detailed, 6-hr training is available on the same topic. Click here to purchase that training

Areas Covered in the Seminar:

Part I: South Korea Regulatory Compliance

• Overview of South Korea’s Healthcare System.
• South Korean Drug Development Process.
• Agency Review Process for Decision-Making.
• Country Establishment Licensing & Procedures.
• Requirements for Conducting Clinical Research.
• South Korea and ICH (International Conference on Harmonization).
• South Korea’s Desire for Innovative Products.
• How South Korea Wants to be Involved in Clinical Trials.
• The Changing KFDA.
• Conducting Meetings with the Agency.
• Korean Philosophy in Risk Evaluation.
• How to Apply for Clinical Trials in South Korea; the CTA.
• Amending the CTA.

Part II: Conducting Clinical Studies in South Korea

• Likely Parameters Defining Clinical Trials; What to Anticipate.
• Clinical Trial Start-Up; ICH GCP and GMP Requirements.
• Importing the IMP & Supplies into South Korea.
• Product Labeling Requirements.
• Finding & Hiring CROs in South Korea.
• Conducting Clinical Trials in South Korea.
• Priority Reviews in South Korea.
• Clinical Trial Pharmacovigilance Reporting.
• CT Close-out and Reporting Requirements.
• Cultural Aspects – Working in South Korea.
• Effectively Working with the Regulators.
• Do’s and Don’ts, Practical Experiences Shared.

Who Will Benefit:

This course will be beneficial to the following personnel in Pharmaceuticals, Medical Devices, and Combination Products manufacturing companies:

• Clinical Trial/ Research Professionals
• Regulatory Affairs Professionals
• QA/ QC
• Manufacturing/ Production
• Global Business Development
• Senior Management

This training will benefit personnel whose responsibilities require knowledge of South East Asian countries' regulatory, clinical, quality and import / export requirements.

Administrative staff responsible for ensuring compliance with IRB's Ethics Applications, Clinical Trial Applications overall GCP, GMP and GLP compliance requirements will also find this training highly relevant.

Global business development and general management requiring an understanding of how regulations and compliance issues are culturally handled along with how best to consider South East Asian countries into one’s Global Business Strategy will profit from attending.

Instructor Profile:

Robert J. Russell, (Bob) is the President of RJR Consulting, Inc. RJR Consulting Inc. specializes in understanding global regulatory issues for the pharmaceutical industry. Bob has more than 25 years of experience working with FDA and the Commission on technical issues as they relate to policy development, regulation, clinical trial and the medical device development process.

Prior to entering the consulting field, Mr. Russell was the Global Director of Regulatory Affairs for two Fortune 100 firms. These companies were major raw material suppliers to the pharmaceutical and medical device industry and one a joint-venture parent of a major pharmaceutical division.