Webinar:

A Global Sponsor’s Guide to Successful Clinical Supply in Japan

Sponsored by: Catalent Pharma Solutions

Focused on:

  • Clinical Supply

Date: 9 June

4

Time: 3PM London/10AM New York

As the 3rd largest pharmaceutical market in the world behind the United States and China, Japan is an important area for clinical trials, bolstered by efforts from the Japanese government and regulatory agencies to create an environment that is welcoming to sponsors from across the globe. The juxtaposition of modern technology and infrastructure in Japan, along with deeply held traditional beliefs and cultural practices, creates a unique environment that can be challenging for clinical trial sponsors to navigate successfully without support from local experts. This webinar will explore the fundamentals of clinical supply for trials in Japan, including an overview of the regulatory framework, cultural considerations, best practices, and the importance of local guidance.

Presented by

Nakaya (Nick) Matsumaru,

General Manager, Catalent Shiga

Nakaya (Nick) Matsumaru is General Manager of Catalent Pharma Solutions’ Shiga, Japan clinical supply facility. In this role, he oversees clinical supply operations in Japan with an emphasis on service delivery, quality and operational excellence thru one-stop-shopping capability. Prior to joining Catalent, he held the role of Senior Director, Supply Chain & Quality Assurance at SymBio Pharmaceuticals. Previously he spent 4 years as Vice President, Operations at AstraZeneca and 7 years in Japan-based supply chain management with Johnson & Johnson and Janssen. He holds a bachelor's degree in Law from Keio University in Tokyo

Key Learning Objectives

  • Explore key aspects of Japan’s regulatory environment that need to be taken into consideration when developing a clinical supply plan and associated timelines
  • Examine the various aspects of supplying clinical studies in Japan including business practices and culturally-driven expectations and preferences
  • Understand the importance of having local representation and support and what resources are available to sponsors interested in running studies in Japan

Audience

  • Clinical Supply Management
  • Clinical Supply
  • Clinical Supplies
  • Supply Chain
  • Clinical Logistics
  • Clinical Operations
  • Clinical Trial Operations
  • Global Clinical Operations
  • Asia / APAC Clinical Operations
  • Vendor Management
  • Consultants
  • CROs