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Regulatory Compliance Training in Japan: A Must for Life Sciences Firms

In an increasingly complex regulatory environment, it’s crucial for life sciences firms to understand the intricacies of Japan’s pharmaceutical and medical device regulations. To help companies navigate these requirements, industry expert Robert J. Russell will be hosting a 90-minute webinar on [Date] titled “Regulatory Compliance Training in Japan”.

Webinar Overview

The webinar is designed for regulatory personnel, administrative staff, and sales or general management employees. It will provide an in-depth overview of the regulatory structure in Japan and cover topics such as:

  • Pre-clinical and clinical requirements
  • Agency processes
  • Dossier maintenance

According to Russell, “Japan’s regulatory environment can be challenging to navigate, especially for companies new to the market. This training is designed to help firms understand the specific procedures and regulations that apply to pharmaceuticals, medical devices, biologics, and combination products.”

Webinar Agenda

During the webinar, attendees will learn about:

  • The current regulatory climate in Japan
  • The role of key agencies such as:
    • Ministry of Health, Labour and Welfare (MHLW)
    • Pharmaceutical and Medical Device Agency (PMDA)
    • Pharmaceutical Affairs and Food Sanitation Council (PAFSC)
  • Common issues that have caused difficulties for life sciences firms in the past
  • Effective compliance procedures and techniques

The training will also touch on cultural issues and how to effectively negotiate with regulators. Russell emphasizes, “Understanding the local culture is crucial when working with Japanese regulatory authorities. This training aims to equip attendees with the knowledge they need to successfully navigate these interactions.”

Who Will Benefit

This webinar is designed for:

  • Regulatory personnel responsible for ensuring compliance with Japan’s regulatory environment
  • Administrative staff responsible for managing regulatory filings and overall compliance requirements
  • Sales or general management employees requiring an understanding of how regulations impact business strategy

Speaker Profile

Robert J. Russell is a global regulatory and CMC expert with 28 years of industry experience in international regulatory management and compliance, global business development, and global supply chain management. He is currently the President & CEO of RJR Consulting, Inc., which assists pharmaceutical, medical device, and biotech industries in understanding regulations affecting compliance and conducting product registrations globally.

Training Details

  • Date: [Date]
  • Time: 90 minutes
  • Price:
    • $199 (one attendee)
    • $[price] (corporate recorded version)
  • Recordings available for 6 months after the live event

Don’t miss this opportunity to gain a deeper understanding of Japan’s regulatory environment and ensure compliance with key regulations. Register now for “Regulatory Compliance Training in Japan” and take your first step towards success in the Japanese market.