Jun 13, 2018 | 10:00 AM | Wednesday

Event Location

Online

161 Mission Falls Lane, Suite 216,, Fremont, CA 94539

Neighborhood: Upper West Side

Description

How Japan interacts with and utilizes ICH standards and how they relate with other national regulatory agencies.


Start on : June 13, 2018 10:00 AM Wednesday
End on : June 13, 2018 11:30 AM Wednesday

Event Details

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.

Agenda:
Japan's Regulatory Structure for the Life Science Product Industries
Demographic
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

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
Email: support@compliance4All.com

What is the Regulatory Structure in Japan 2018

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