South Korea: Navigating the Clinical Trial and Regulatory Environment |
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This Video specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceutical Products in South Korea. The video 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 video will also discuss how personnel can best address the conflicts that sometimes arise and the approach that can best be taken for resolution. This video 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. For More Information Contact - Organization: NetZealous BDA GlobalCompliancePanel Website: http://www.globalcompliancepanel.com/ Email: support@globalcompliancepanel.com Help us caption & translate this video! http://amara.org/v/Notn/ |