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Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences

Event Details

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences

Time: March 19, 2014 from 10am to 11:30am
Location: Online Event
Street: 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA
City/Town: Fremont
Website or Map: http://bit.ly/1k26KJ6
Phone: 8004479407
Event Type: webinar, pharma, medical, clinical, health
Organized By: John Robinson
Latest Activity: Feb 28, 2014

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Event Description

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.

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

Who Will Benefit:
  • 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
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. 

Quick Contact:

GlobalCompliancePanel
USA Phone:800-447-9407
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com
Event Link - http://bit.ly/1k26KJ6

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