South Korea: Navigating the Clinical Trial and Regulatory Environment - Webinar By GlobalCompliancePanel

Submitted by Anonymous on Fri, 04/13/2012 - 01:17

Start: 05/01/2012 10:00 am

Timezone: America/New York

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.

The current regulatory climate will be discussed in depth and several examples will be provided to illustrate effective compliance procedures and techniques. Common issues which have caused difficulties for Life Sciences firms will also be discussed. Course content will also explain how South Korea interacts with and utilizes ICH standards and how they relate with other national regulatory agencies.

The course will also discuss how personnel can best address the conflicts that sometimes arise and the approach that can best be taken for resolution. This course will also be useful for sales or general management personnel who need an overview of the Regulatory Compliance requirements within South Korea and how best to consider the country into one's Business Strategy.

Agenda of the Session:
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
South Korea and ICH (International Conference on Harmonization)
Requirements for Clinical Trials in South Korea
The Changing KFDA
Product Labeling Requirements
Cultural Aspects - Working in South Korea
Effectively working with the Regulators; Do's and Don'ts, Practical Experiences Shared
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.