RAPS pre-approved webinar on "Japan -Regulatory Filing Requirements and Compliance Processes for Life Sciences" from GlobalCompliancePanel
GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize a RAPS pre-approved webinar on the topic, "Japan -Regulatory Filing Requirements and Compliance Processes for Life Sciences" on March 20.
- San Jose, CA (1888PressRelease) March 20, 2013 - Description:
This training session is about the regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan. In addition to covering topics relating to pre-clinical and clinical requirements; this course will also take a look at the structure of the regulatory agencies in Japan.
While elaborating on the current regulatory climate in Japan; the speaker will offer examples of effective compliance procedures and techniques. He will familiarize participants with a few common issues and concerns that professionals and firms dealing with Life Sciences usually face when they do business with Japan.
The speaker will also explain how Japan interacts with and utilizes ICH standards. He will also describe how Japan's way of working with other national regulatory agencies influences their business. The webinar will show ways by which to address the conflicts that sometimes arise and suggest the optimal ways of doing this.
This is the outline for the course:
- Japan's Regulatory Structure for the Life Science Product Industries
- Beginning Your Company Involvement in Japan
- Life Science Regulations and the Regulatory Processes in Japan
- Japan's Use of ICH Standards/Principles
- Marketing Authorization Processes - Filings & Registrations
- Variations: Changes to Marketed Products
- Renewals
- The Do's and Don'ts of Regulatory Involvement
When: March 20, 10:00 AM PDT | 01:00 PM EDT
By whom:
Robert J. Russell is 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, and 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.
For whom:
The webinar 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
Duration: 90 minutes
To enroll for this webinar, contact
webinars ( @ ) globalcompliancepanel dot com
Phone: 800-447-9407
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