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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. 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. For the past 9 years, Bob has been President of RJR Consulting, Inc. The company assists the pharmaceutical, medical device and biotech industries in understanding and complying with International Regulations affecting compliance, new product development, manufacturing and quality assurance. Contact Information: NetZealous LLC, DBA GlobalCompliancePanel 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA USA Phone:800-447-9407 Fax: 302-288-6884 webinars@globalcompliancepanel.com http://www.globalcompliancepanel.com Event Link - http://bit.ly/1ccd8VL
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