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Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences

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					GlobalCompliancePanel                                                   Your Gateway to Regulatory Compliance

Live Webinar on

Japan - Regulatory Filing Requirements and Compliance
Processes for Life Sciences

Date: Wednesday, March 20, 2013                                         Time: 10:00 AM PST | 01:00 PM EST

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

Course "Japan - Regulatory Filing Requirements and Compliance
Processes for Life Sciences" has been pre-approved by RAPS as
eligible for up to 1.5 credits towards a participant's RAC recertification
                                                                                    Register Now
upon full completion.


Overview:
This course specifically focuses on the overall regulatory compliance requirements and procedures
for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan. The course will
cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure
of the regulatory agencies in Japan. 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.


Areas covered in the session:

    l   What is the Regulatory Structure in Japan
    l   Understanding the specific procedures for Pharmaceuticals, Medical Devices, Biologics and
        Combination Products
    l   How to begin your company involvement in Japan
    l   How current regulations effect product development strategies
    l   Pricing issues
    l   Understanding the concerns/issues of Japanese Regulatory Personnel
    l   Understanding the Local Culture: How to negotiate with the regulators
    l   Information necessary for effective submissions
    l   Maintenance of Authorized Products



Who Will Benefit:                                          About Speaker

                                                           Robert J. Russell
    l   Regulatory Personnel
                                                           President, RJR Consulting, Inc.
        whose responsibilities
                                                           For the past 9 years, Bob has been
        require knowledge of                               President of RJR Consulting, Inc. The
        Japan's regulatory                                 company assists the pharmaceutical,
        environment                                        medical device and biotech industries
                                                           in understanding and complying with
    l   Administrative staff                               International Regulations affecting
        responsible for ensuring                           compliance, new product
        compliance with regulatory                         development, manufacturing and
                                                           quality assurance. RJR has offices in
        filings and overall
                                                           Columbus, OH, Washington, DC,
        regulatory compliance                              Brussels, Belgium with exclusive
        requirements will also find                        affiliates across Asia and Latin
        this training highly relevant                      America.   ...more
    l   Any sales or general
        management employee
        requiring an understanding
        of how regulations and
        compliance issues impact
        the organization will also
        benefit




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DOCUMENT INFO
Description: This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Japan. 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.