Regulatory Compliance Training in Japan: A Must for Life Science Professionals
In today’s rapidly evolving life science industry, staying up-to-date with regulatory compliance requirements is crucial to ensure successful product launches and business operations. For companies operating in Japan, understanding the country’s unique regulatory framework is essential to navigate the complex clinical trial process, marketing authorization procedures, and post-marketing requirements.
Why Attend
This training is designed for anyone responsible for ensuring compliance with regulatory filings and overall GCP, GMP, and GLP compliance requirements in Japan. Attendees will gain valuable insights into the regulatory structure, clinical trial processes, and marketing authorization procedures, as well as practical tips on how to effectively navigate the complex regulatory environment.
Course Agenda
The training will cover the following areas:
- Japan’s Regulatory Structure for Life Science Product Industries
- Country Healthcare System and Regulatory Framework
- Clinical Trials: Conducting Clinical Trials in Japan
- Marketing Authorization Processes: Product Registrations and Licensing
- Variations Processing: Changes to Marketed Products
- License Renewals: Process and Timing for Renewing Licenses
Real-World Experience
The training will feature real-world examples and case studies on actual interactions with the Japanese regulatory agency, PMDA. Attendees will learn how to apply cultural knowledge needed for success in Japan’s regulatory environment.
Who Should Attend
This training is ideal for:
- Clinical/pharma & device personnel
- Clinical trial project managers
- Monitors/CRAs
- QA/QC personnel
- Pharmacovigilance reporting personnel
- Regulatory personnel responsible for Japan’s regulatory and clinical trial environment
- Global supply chain personnel
- Manufacturing personnel
- Global business development personnel
Instructor Profile
Robert J. Russell, President of RJR Consulting, Inc., has 28 years of 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.
Purchase Options
The training is available in two formats:
- $299.00: Unlimited viewing for one person for six months
- $399.00: Downloadable file for usage in one location only
Don’t miss this opportunity to stay ahead of the regulatory curve in Japan. Register now and gain a comprehensive understanding of Japanese regulatory compliance requirements.