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    Japan Regulatory Compliance Requirements for Life Science Products

    Start Date : October 25, 2018
    End Date : October 26, 2018
    Time : 9:00 am to6:00 pm

    Phone : 800-385-1627
    Email : globalcompliancepanel@gmail.com

    Location :
    Courtyard Seattle Sea-Tac Area 16038 West Valley Highway Tukwila Washington 98188 USA

    Website

    Description



    Course "Japan Regulatory Compliance Requirements for Life Science Products" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.


    Overview:


    This 2-Day seminar covers the details of the Regulatory Requirements for a wide-range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices and Combination Products. The syllabus also covers the change in Japan caused by the re-write of the Pharmaceutical Affairs Law [PAL] into the Pharmaceuticals & Medical Device Law [PMDL] and the country's latest update to GMP requirements.


    The information presented will help you gain a comprehensive understanding of the Regulatory Structure, Product Classification, Clinical Trial Requirements, Marketing Authorization Procedures, Variations Processing, License Renewals, GMP requirements and cultural working aspects within the Regulatory Environment in Japan. It will prepare you for regulatory approval processes, Agency meetings, the complexities of running clinical studies, the importance of partner selection and also add the cultural knowledge needed for success in-country. The recent changes made by PMDA to be more sponsor and applicant-friendly, along with the impact this has had on dossier review times, will be shared. Real world experiences on actual interactions with the Agency, since these changes have been implemented, will also be discussed.




    Course Objective:


    Attendees will leave this Course clearly understanding the Regulatory Procedures necessary to be successful in getting your products to market in a timely fashion. This Course has been updated to provide participants with competitive insight into:





    Who will benefit:


    This seminar will benefit Project Team Members, whose specific functional discipline comes from:



    Agenda:


    Day 1 Schedule




    Part I: Japan Regulatory Compliance




    Lecture 1:


    Japan's Regulatory Structure for the Life Science Product Industries





    Lecture 2:


    Beginning Your Company Involvement in Japan





    Lecture 3:


    Objectives of the Rules Governing Medicinal Procedures


    Life Science Regulations and the Regulatory Processes in Japan





    Lecture 4:


    Japan's Use of ICH Standards / Principles





    Lecture 5:


    Starting-Up and Conducting Clinical Trials



    Day 2 Schedule




    Part II:




    Lecture 1:


    Marketing Authorization Processes - Product Registrations / Licensing





    Lecture 2:


    Variations: Changes to Marketed Products





    Lecture 3:


    License Renewals





    Lecture 4:


    Comparing and Contrasting Japan's Procedures vs. U.S. FDA





    Lecture 5:


    How and When to Influence the Regulatory Process



     


    Speaker


    Robert Russell


    President / CEO , RJR Consulting, Inc. 

    Robert J. Russell (Bob) is President / CEO of RJR Consulting, Inc. which specializes in helping clients navigate through Global Regulatory Compliance requirements for Pharmaceuticals, Medical Devices, Biologics, Combination Products and Dietary Supplement / OTC products. Prior to founding the company 17 years ago, Bob had more than 27 years of experience in CMC, Global Business development and Regulatory Affairs for two Fortune 200 firms developing innovative Pharmaceuticals and Medical Devices.


    Bob has specific expertise helping companies expand into new regions globally and meet establishment and licensing requirements, clinical trial data expectations, marketing authorization / registration preparation, meet variations / amendment filing responsibilities and license renewal filings. He has practical experience counseling Pharmaceutical and Device manufacturers through GMP, GCP, GLP requirements, CE marking / ISO certifications, Drug / Device Master File preparation, mock pre-audits and issues management with Global Healthcare Authorities. Bob is a past member of the International GMP Working Group on Standards for Industry harmonization with several colleagues from Europe. He holds a B.S. And M.S. in Chemistry.


     


    Location:  Seattle, WA Date: October 25th & 26th, 2018 and Time: 9:00 AM to 6:00 PM


    Venue:  Courtyard Seattle Sea-Tac Area   16038 West Valley Highway Tukwila Washington 98188 USA


     


    Price:


    Price: $1,495.00 (Seminar Fee for One Delegate) Register for 5 attendees Price: $4,485.00 $7,475.00 You Save: $2,990.00 (40%)* Register for 10 attendees Price: $8,222.00 $14,950.00 You Save: $6,728.00 (45%)*


    Sponsorship Program benefits for seminar


    For More Information- https://www.globalcompliancepanel.com/control/sponsorship 


    Contact us today!


    NetZealous LLC DBA GlobalCompliancePanel


    john.robinson@globalcompliancepanel.com  


    Toll free: +1-800-447-9407


    Phone: +1-510-584-9661


     Website: http://www.globalcompliancepanel.com


     


    Registration Link - https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901465SEMINAR?SEO


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    Registration Info

    https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901465SEMINAR?meetings4docs-oct-seo

    Contact the Organizer

    Organized by

    Organized by globalcompliancepanel

    NetZealous LLC DBA GlobalCompliancePanel ,
    161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA.

    GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and cost-effective while being convenient.

    GlobalCompliancePanel imparts knowledge of best practices across a broad range of user-friendly mediums such as webinars, seminars, conferences and tailored, individualized consulting. These help organizations and professionals implement compliance programs that meet regulatory demands and put business processes in place.

    GlobalCompliancePanel focuses primarily on providing extensive and quality training in these core areas and anything related to them:

    • Risk Management
    • Regulatory Compliances
    • Corporate Governance
    • Quality Management
    Tel: 800-447-9407
    Email: globalcompliancepanel@gmail.com
    Website: https://www.globalcompliancepanel.com/


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