Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences 2018

Topics

• Understanding the specific procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products
• What is the Regulatory Structure in Japan
• How current regulations effect product development strategies
• How to begin your company involvement in Japan
• Understanding the concerns/issues of Japanese Regulatory Personnel
• Pricing issues
• Information necessary for effective submissions
• Understanding the Local Culture: How to negotiate with the regulators
• Maintenance of Authorized Products

Who should Attend

• Administrative staff responsible for ensuring compliance with regulatory filings and overall regulatory compliance requirements will also find this training highly relevant
• Regulatory Personnel whose responsibilities require knowledge of Japan`s regulatory environment
• Any sales or general management employee requiring an understanding of how regulations and compliance issues impact the organization will also benefit