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2-day In-person Seminar on Biosimilars At San Francisco

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     2-day In-person Seminar on Biosimilars


                                                                                                                                      
     Course "2-day In-person Seminar on Biosimilars" has been pre-
     approved by RAPS as eligible for up to 12 credits towards a
                                                                                                 Register Now                         
     participant's RAC recertification upon full completion.


    Date & Time:
                                                                                            Instructor Profile:
     May 10th and May 11th 2012         8 am to 5 pm PDT

     Duration: 2 Days                   Instructor: Steven S Kuwahara                                 Steven S Kuwahara
                                                                                                     Founder & Principal, GXP
     Location: San Francisco,                                                                           Biotechnology, LLC
                                        Price : $1495.00   (for one participant)
     Marriott Marquis Downtown

                                                                                            Steven S. Kuwahara, Ph.D. is the
                                                                                            founder and Principal of GXP
    Overview:
                                                                                            BioTechnology LLC, a consulting firm
    This course will present the regulations and guidelines that apply to                   that works in the areas covered by
    the development and production of biosimilars. In some cases these                      the GLP and GMP of drugs, biologics,
    will not be regulations, but needs that, if met, will increase the                      and nutraceuticals. Steve has over
    efficiency of activities as the work on a product proceeds, starting                    30 years of experience in
                                                                                            supervising quality control
    with the early development process. The course will present the
                                                                                            laboratories, including an animal
    guidance documents and the related regulations while describing the
                                                                                            testing facility, and in performing
    activities that will be required to meet the conditions under which a                   GLP and GMP audits of internal and
    biosimilar may be manufactured and licensed.                                            external testing laboratories . Steve
                                                                                            has participated in the development
                                                                                            of drugs and biologicals through all
    Areas Covered in the Session:
                                                                                            phases of clinical research and final
                                                                                            product production. ...more
    Day 1, May 10, 2012

    Lecture 1: Biologics in general and what makes them so different
                                                                                           Suggest a Topic       More Webinars

       l   Definitions and manufacturing considerations                                      Your Necessity is our Priority


    Lecture 2: Introduction and Terminology of Biosimilars


       l   What are biosimilars and what about all of the terms that
           relate to them?                                                                                    


    Lecture 3: Considerations for demonstrating biosimilarity I


       l   Structural and functional analysis
       l   Animal Data


    Lecture 4: Considerations for demonstrating biosimilarity II                    


       l   Human Clinical Studies
       l   Post marketing studies and discussions with FDA


    Day 2, May 11, 2012

    Lecture 5: Quality Factors in demonstrating biosimilarity I


       l   Culturing and Manufacturing
       l   Physicochemical factors


    Lecture 6: Quality Factors in demonstrating biosimilarity II


       l   Reference substance comparibility
       l   Stability Studies and characteristics of the finished drug
           product


    Lecture 7: Regulatory Matters I


       l   Biosimilarity and Interchangability
       l   Pediatric provisions under the pediatric rule and the biosimilars
           rules


    Lecture 8: Regulatory Matters II
     l   Submission of a Biologics License Application (BLA)
            ¡ What is a BLA like?

     l   Exclusivity: Innovator (Reference) Drug and the biosimilars
             ¡ What about orphan designations?



 Click here to register for this seminar


  Who Will Benefit:


     l   Directors
     l   Managers
     l   Supervisors and lead workers in Manufacturing
     l   Process Development
     l   Regulatory Affairs
     l   Quality Assurance and Quality Control



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
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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: This course will present the regulations and guidelines that apply to the development and production of biosimilars. In some cases these will not be regulations, but needs that, if met, will increase the efficiency of activities as the work on a product proceeds, starting with the early development process. The course will present the guidance documents and the related regulations while describing the activities that will be required to meet the conditions under which a biosimilar may be manufactured and licensed.