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Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences - Part I and Part II - Webinar By GlobalCompliancePanel

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Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences - Part I and Part II - Webinar By GlobalCompliancePanel Powered By Docstoc
					                                                                                                                                          


    Live Webinar            on

        Japan - Regulatory Filing Requirements and Compliance Processes for
        Life Sciences - Part I and Part II

    Date & Time:                                                                                                                           

     Tuesday, January 18, 2011                10:00 AM PST | 01:00 PM EST
                                                                                                      Register Now                            
     Duration: 3 Hours                        Instructor: Robert J. Russell

     Location: Online                         Price : $395.00   (for one participant)

                                                                                                 Instructor Profile:

    Agenda for Part I:
                                                                                                            Robert J. Russell
    Japan - Understanding the Dynamics of the Changing Structure,                                        President, RJR Consulting,
    Regulatory Requirements and Compliance Processes for Life                                                       Inc.
    Science Products
    l   Japan's Regulatory Structure for the Life Science Product                                For the past 9 years, Bob has been
                                                                                                 President of RJR Consulting, Inc. The
        Industries
                                                                                                 company assists the pharmaceutical,
        ¡   Demographic Overview                                                                 medical device and biotech
        ¡   Regulatory Framework:  Key Agencies Involved / Reporting                             industries in understanding and
            Structure                                                                            complying with International
        ¡   Recent Changes to MHLW / PMDA to Speed Review                                        Regulations affecting compliance,
                                                                                                 new product development,
            n   MHLW (Ministry of Health, Labour and Welfare)
                                                                                                 manufacturing and quality
            n   PMDA  (Pharmaceutical and Medical Device Agency)                                 assurance. RJR has offices in
            n  PAFSC (Pharmaceutical Affairs and Food Sanitation Council)                        Columbus, OH, Washington, DC,
        ¡   Patents and Trademark Considerations                                                 Brussels, Belgium with exclusive
    l   Beginning Your Company Involvement in Japan                                              affiliates across Asia and Latin
                                                                                                 America. Bob has 28 years of past
        ¡   Local Office and Personnel Requirement Options
                                                                                                 industry experience as a CMC
        ¡ Language Requirements                                                                  specialist, R&D Director and Global
        ¡ Possible License Types                                                                 Director of Regulatory Affairs for
    l   Objectives of the Rules Governing Medicinal Procedures                                   Merion Merrill Dow pharmaceuticals
                                                                                                 and Cordis-Dow medical devices. He
        ¡ Market Authorization Holder Overview
                                                                                                 has a BS / MS degree in Chemistry.
    l   Life Science Regulations and the Regulatory Processes in Japan
                                                                                                 ...more
        ¡   Pre-Clinical
        ¡   Conducting Clinical Trials
        ¡   New Product Registrations & Filings
                                                                                                Suggest a Topic       More Webinars
        ¡ Post-Marketing Requirements
        ¡ Pricing & Reimbursement                                                                 Your Necessity is our Priority
    l   Japan's Use of ICH Standards / Principles
        ¡   GCP
        ¡   GMP
        ¡   CTD / e-CTD Submissions
    l   Starting-Up and Conducting Clinical Trials                                                                 
        ¡   Clinical Trial Start-Up process
            n   Japan's Effort to Reduce "The Drug Lag"
            n   Japan's Desire to Eliminate Bridging Studies and Participate
                in Ph. III Global Trials


    Agenda for Part II:
    Japan - Understanding the Dynamics of the Changing Structure,
                                                                                         

    Regulatory Requirements and Compliance Processes for Life
    Science Products
    l   Marketing Authorization Processes – Filings & Registrations
        ¡   Pharmaceutical Affairs Law (PAL) & Drug Registration
        ¡   Medical Devices
        ¡   Biologic Considerations
        ¡   Developing Combination Products; Classification and Licensing
            Review
        ¡   Drug Master File (DMF) Use in Japan
        ¡   Labeling Requirements
        ¡ Package Insert Requirements
    l   Variations: Changes to Marketed Products
        ¡  Types of Variations
        ¡  Variation Filings and Typical Review Times
    l   License Renewals
        ¡   Japan's Process; What has recently changed
        ¡   License Terms
        ¡   Maintenance Responsibilities
 l   Comparing and Contrasting Japan’s Procedures vs. U.S. FDA
     ¡   Comparison of Processes
     ¡   Agency Interactions
     ¡ Accepted Practices
 l   How and When to Influence the Regulatory Process
     ¡   Japanese Way of Thinking / Coming to Agreement
     ¡   Important Cultural Issues for Consideration
     ¡   The Do's and Don'ts of Regulatory Involvement in Japan
 l   How to Use Regulations / Regulatory Contacts to Your
     Advantage
     ¡   Agency Interactions
     ¡   Business Impact Within and Outside of Japan
     ¡   Professionalism in Regulatory Affairs


 Click here to register for this webinar


  Who Will Benefit:

 l   Regulatory personnel whose responsibilities require knowledge of
     Japan's regulatory environment.
 l   Administrative staff responsible for ensuring compliance with
     regulatory filings and overall regulatory compliance requirements
     will also find this training highly relevant.
 l   Any sales or general management employee requiring an
     understanding of how regulations and compliance issues impact
     the organization will also benefit.


It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely
benefit from this program.

For more information, please contact the event coordinator. We look forward to seeing you at the webinar.

Best regards,
Event-coordinator
GlobalCompliancePanel



About GlobalCompliancePanel
GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online
compliance training by creating a single window of learning opportunities for compliance professionals & providing a
forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our
commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training
sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions,
giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs.
GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learning
and development on/through our website. Keep track of all webinars arranged for your industry through notifications &
event calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for
professionals.


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www.globalcompliancepanel.com
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1200 Wilmington DE 19801

Phone: 800-447-9407 or
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DOCUMENT INFO
Description: Agenda for Part I: Japan - Understanding the Dynamics of the Changing Structure, Regulatory Requirements and Compliance Processes for Life Science Products * Japan's Regulatory Structure for the Life Science Product Industries o Demographic Overview o Regulatory Framework: Key Agencies Involved / Reporting Structure o Recent Changes to MHLW / PMDA to Speed Review MHLW (Ministry of Health, Labour and Welfare) PMDA (Pharmaceutical and Medical Device Agency) PAFSC (Pharmaceutical Affairs and Food Sanitation Council) o Patents and Trademark Considerations * Beginning Your Company Involvement in Japan o Local Office and Personnel Requirement Options o Language Requirements o Possible License Types * Objectives of the Rules Governing Medicinal Procedures o Market Authorization Holder Overview * Life Science Regulations and the Regulatory Processes in Japan o Pre-Clinical o Conducting Clinical Trials o New Product Registrations & Filings o Post-Marketing Requirements o Pricing & Reimbursement * Japan's Use of ICH Standards / Principles o GCP o GMP o CTD / e-CTD Submissions * Starting-Up and Conducting Clinical Trials o Clinical Trial Start-Up process Japan's Effort to Reduce "The Drug Lag" Japan's Desire to Eliminate Bridging Studies and Participate in Ph. III Global Trials Agenda for Part II: Japan - Understanding the Dynamics of the Changing Structure, Regulatory Requirements and Compliance Processes for Life Science Products * Marketing Authorization Processes – Filings & Registrations o Pharmaceutical Affairs Law (PAL) & Drug Registration o Medical Devices o Biologic Considerations o Developing Combination Products; Classification and Licensi