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 Industries
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)
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
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
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