At the Clinical Safety & Pharmacovigilance Unit, we carry out safety monitoring and risk management to ensure the safety of patients through a medicinal product lifecycle, from development to post-marketing. Specifically, we analyze safety information collected on our products from around the globe and provide information necessary for risk management to medical sites in a timely manner to promote the appropriate use of medicinal products and contribute to the safety of patients.
Looking ahead toward 2030, Daiichi Sankyo is working on the global expansion of oncology medicinal products and conducting research and development in a new field called "new modalities." Along with such initiatives, an increase in the amount of safety information and the diversity and complexity of risk management issues are already occurring. Therefore, continuing to respond to these new challenges will be crucial for us in the future. We also need to further refine our operations in order to continue to carry out timely risk management during development and post-marketing and respond to safety-related regulatory standards that are becoming stricter around the world.
Against this background, the Clinical Safety & Pharmacovigilance Unit strives to achieve high-quality management of adverse events, make the operational process more efficient, and strengthen the global structure and how it functions.
To achieve the high-quality management of adverse events, it is important to promptly analyze risks and take appropriate safety measures in a timely manner. Through such measures, we are striving to strengthen the system for linking analysis results to action as quickly as possible by identifying risks based on various types of information and communicating with doctors so they can advise patients.
We are working on streamlining the adverse event case handling process at a global level to make the operational process more efficient, because the amount of safety information considerably increases as the products expand worldwide, especially in the field of oncology.
Specifically, regarding global system and functional enhancement, in order to speed up global decision-making, we will strive to understand issues from both global and regional perspectives and build a system that enables prompt, optimal decision-making.
Clinical safety and pharmacovigilance operations takes pride in supporting the business foundation of the Daiichi Sankyo group of companies by systematically understanding the situation, quickly taking the necessary actions, and making the safety of patients our top priority in tackling our daily activities.
After engaging in the development of new medicinal products, I have been involved in clinical safety and pharmacovigilance operations for a long time. As Daiichi Sankyo undergoes transformation under the 5-year business plan, the Clinical Safety & Pharmacovigilance Unit must further accelerate its own transformation as well. The Unit is increasingly conscious of the need to change and grow, and I believe that one of my roles as the leader is to nurture colleagues who can think, respond to change, and act spontaneously.
We will strive to achieve our company’s Purpose by delivering high-quality safety information as quickly as possible for all Daiichi Sankyo products, thereby contributing to the safety of patients around the world.