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2018 - What is the Regulatory Structure in Japan 2018



VenueFremont, USA - United States USA - United States

KeywordsClinical Trials; Post-Marketing; Risk Management


Topics/Call fo Papers

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.
Japan's Regulatory Structure for the Life Science Product
Regulatory Framework: Key Agencies Involved / Reporting
MHLW (Ministry of Health, Labour and Welfare)
PMDA (Pharmaceutical and Medical Device Agency)
PAFSC (Pharmaceutical Affairs and Food Sanitation Council)
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
Speaker Profile:
Robert J. Russell For the past 9 years, He 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.
Event Fee: One Dial-in One Attendee Price: US$150.00
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407

Last modified: 2018-04-20 15:57:21