South Korea: Navigating the Clinical Trial and Regulatory Environment

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					GlobalCompliancePanel                                                Your Gateway to Regulatory Compliance

Live Webinar on

South Korea: Navigating the Clinical Trial and Regulatory
Environment

Date: Thursday, December 12, 2013                                    Time: 10:00 AM PST | 01:00 PM EST

   Duration:    90 Minutes
   Location:    Online                                                          Register Now
 Instructor:    Robert J. Russell

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.


Areas covered in the session:

    l   What is the Regulatory Structure in South Korea
    l   Understanding the specific procedures for Pharmaceutical Products
    l   How to begin your company involvement in South Korea
    l   Requirements for Clinical Trials in South Korea
    l   South Korean Drug Development Process
    l   The Changing KFDA
    l   Understanding the Local Culture: How to negotiate with the regulators



Who Will Benefit:                                    About Speaker

                                                     Robert J. Russell
    l   This course will be of benefit to
                                                     President, RJR Consulting, Inc.
        regulatory personnel whose                   Robert For the past 9 years, Bob has been President
        responsibilities require knowledge           of RJR Consulting, Inc. The company assists the
                                                     pharmaceutical, medical device and biotech industries
        of South Korea's regulatory
                                                     in understanding and complying with International
        environment. Administrative staff            Regulations affecting compliance, new product
        responsible for ensuring compliance          development, manufacturing and quality assurance.
        with regulatory filings and overall          RJR has offices in Columbus, OH, Washington, DC,
                                                     Brussels, Belgium with exclusive affiliates across Asia
        regulatory compliance requirements           and Latin America. Bob has 28 years of past industry
        will also find this training highly          experience as a CMC specialist, R&D Director and
        relevant. Any sales or general               Global Director of Regulatory Affairs for Merion Merrill
                                                     Dow pharmaceuticals and Cordis-Dow medical
        management employee requiring an
        understanding of how regulations
                                                     devices.   ...more
        and compliance issues impact the
        organization will also benefit.




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