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Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences

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


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participant's RAC recertification upon full completion.

Date & Time:

Instructor Profile:

Thursday, July 5, 2012

10:00 AM PDT | 01:00 PM EDT

Duration: 90 Minutes

Instructor: Robert J. Russell

Location: Online

Price : $245.00

Robert J. Russell President, RJR Consulting, Inc.

(for one participant)

For the past 9 years, Bob has been President of RJR Consulting, Inc. The company assists the pharmaceutical, medical device and biotech industries in understanding and complying with International Regulations affecting compliance, new product development, manufacturing and quality assurance. RJR has offices in Columbus, OH, Washington, DC, Brussels, Belgium with exclusive affiliates across Asia and Latin America. Bob has 28 years of past industry experience as a CMC specialist, R&D Director and Global Director of Regulatory Affairs for Merion Merrill Dow pharmaceuticals and Cordis-Dow medical devices. He has a BS / MS degree in Chemistry. ...more

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. The current regulatory climate will be discussed in depth and several examples will be provided to illustrate effective compliance procedures and techniques. Common issues which have caused difficulties for Life Sciences firms will also be discussed. Course content will also explain how Japan interacts with and utilizes ICH standards and how they relate with other national regulatory agencies. The course will also discuss how personnel can best address the conflicts that sometimes arise and the approach that can best be taken for resolution.

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This course will also be useful for sales or general management personnel who need an overview of the Regulatory Compliance requirements within Japan and how best to consider the country into one's Business Strategy.

Learning Objectives: This course is designed to provide an overview of the regulatory environment in Japan and will provide training in: l

What is the Regulatory Structure in Japan


Understanding the specific procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products How to begin your company involvement in Japan How current regulations effect product development strategies

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Pricing issues Understanding the concerns/issues of Japanese Regulatory Personnel Understanding the Local Culture: How to negotiate with the regulators Information necessary for effective submissions Maintenance of Authorized Products

Areas Covered in the Session: l

Japan's Regulatory Structure for the Life Science Product Industries ¡ Demographic ¡ Regulatory Framework: Key Agencies Involved / Reporting Structure ¡ ¡

MHLW (Ministry of Health, Labour and Welfare) PMDA (Pharmaceutical and Medical Device Agency)




PAFSC (Pharmaceutical Affairs and Food Sanitation Council)

Beginning Your Company Involvement in Japan ¡ Local Office and Personnel Requirements ¡ License Types ¡ Overseas Manufacturers Life Science Regulations and the Regulatory Processes in Japan ¡ Pre-Clinical ¡ ¡ ¡ ¡

Conducting Clinical Trials New Product Registrations & Filings Adverse Drug Reactions Post-Marketing Requirements

Maintenance of Licensed Products Reimbursement, Audits ¡ Risk Management Japan's Use of ICH Standards/Principles ¡ ¡

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Marketing Authorization Processes - Filings & Registrations ¡ Drugs, Medical Devices, Biologics ¡ Similar Products & Devices ¡ Labelling Requirements ¡ PIL Variations: Changes to Marketed Products

Renewals ¡ Cultural Issues ¡ How and When to Influence the Regulatory Process The Do's and Don'ts of Regulatory Involvement

Click here to register for this webinar Who Will Benefit: l



Regulatory Personnel whose responsibilities require knowledge of Japan's regulatory environment Administrative staff responsible for ensuring compliance with regulatory filings and overall regulatory compliance requirements will also find this training highly relevant 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. GlobalCompliancePanel 1000 N West Street Suite, 1200 Wilmington DE 19801 Phone: 800-447-9407 or Fax your PO to: 302-288-6884 If you do not wish to receive this training alerts from GlobalCompliancePanel Click Unsubscribe

Japan - Regulatory Filing Requirements and Compliance Processes forLife Sciences  

This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biol...

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