Live Webinar
on
Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences
Date & Time: Tuesday, April 17, 2012
10:00 AM PDT | 01:00 PM EDT
Duration: 90 Minutes
Instructor: Robert J. Russell
Location: Online
Price : $245.00
Register Now
(for one participant)
Instructor Profile:
Overview:
Robert J. Russell President, RJR Consulting, Inc.
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,
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
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.
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
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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
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Areas Covered in the Session: l
Japan's Regulatory Structure for the Life Science Product Industries ¡ Demographic ¡ Regulatory Framework: Key Agencies Involved / Reporting Structure ¡ ¡ ¡
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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 ¡
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Variations: Changes to Marketed Products
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Renewals ยก Cultural Issues
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ยก 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
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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
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