TOKYO, October 22, 2021 -- Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced the following organizational changes, effective January 1, 2022.

1. Establishment of Digital Transformation Unit

• Digital Transformation Unit will be newly established to reorganize the digital and IT functions. Digital and IT Supervisory Div. will be abolished accordingly.
• Digital Strategy Dept. and IT Solutions Dept., both currently exist under Digital and IT Supervisory Div., will be transferred to Digital Transformation Unit.

[Overview]
By reorganizing the digital and IT functions as a unit, Digital Transformation Unit will further promote company-wide digital and IT strategies. By deeply involved in individual IT and Digital projects, the Unit will accumulate and deploy knowledge, enhance governance and contain costs so that the company may accelerate the realization of digital transformation (DX), one of the key drivers in TOP I 2030.

2. Reorganization of Drug Safety Div. and Quality and Regulatory Compliance Unit

• Safety Strategy Dept. will be renamed Safety Science Dept., and Pharmacovigilance Dept. will be renamed Drug Safety Data Management Dept. This is to strengthen the safety science and data management functions by clarifying the roles of each function.
• The data science functions spread across each department will be reorganized as follows:
  ・Planning and analysis relating to safety strategy: Safety Science Dept.
  ・Surveillance management and solution provision: Risk Communication Dept.
• Basic business operations of each department and functions related to DX will be consolidated in Drug Safety Coordination Dept. To achieve both quality and efficiency in quality management, reorganization with Quality & Regulatory Compliance Unit will be carried out.
• Real World Data Science Dept. will be abolished, and its pharmacovigilance function will be transferred to other departments.

[Overview]
With RED SHIFT in mind, reorganization will take place to strengthen the safety science function and thereby ensure consistent and appropriate risk assessment and risk management of Chugai products from the early development stage to the post-marketing phase. The reorganization also aims to strategically and quickly utilize the data science function as it relates to real-world data including post-marketing surveillance.

RED: Research & Early Development