Full-day Virtual Seminar - South Korea: Navigating the Regulatory and Clinical Trial Environment

Why Should You Attend:

This 6-hr training will provide valuable insights into how regulations and compliance issues are culturally handled in South Korea.

This course specifically focuses on the regulatory compliance requirements and procedures for conducting Clinical Trials on Pharmaceutical Products in South Korea. 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.
• Clinical Trial Pharmacovigilance Reporting.

Agenda:

Part I: South Korea Regulatory Compliance

• Overview of South Korea's Healthcare System.
• South Korea's Regulatory Agencies Structure and Responsibilities.
• 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).
• Requirements for Clinical Trials in South Korea.
• 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

• South Korea's Clinical Investigational Plan (CIP).
• 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 Korea’s 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 Korea 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.

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