Dr. Haruko Yamamoto, a specialist in neurology, is now the Executive Director at the National Cerebral and Cardiovascular Center (NCVC), where she also serves as the Director of the Dept. of Data Science and the Dept. of Clinical Trial Management. She has led several investigator-initiated clinical studies evaluating new drugs and high-risk medical devices. After leading the academic research organization at NCVC for over ten years, she was appointed Chief Medical Officer/ Associate Executive Director at the Pharmaceutical and Medical Devices Agency til 2023. She serves as the chair of the DIA Advisory Council of Japan and a member of the Medical Device Symposium program committee. Dr. Yamamoto holds a PhD in medicine from Osaka University.

Rie Matsui is Senior Director, Regional Labeling Head for APAC, International Labeling Group, Global Regulatory Science, Pfizer Japan. She is also the Head, External Engagements for ILG. She is the founder of Asia Labeling Hub at Pfizer that has created various local label updates for more than 25 countries in Asia. She was a member of the Advisory Council of DIA Japan until 2020 and received the DIA Japan regional award in 2015. Her papers were published in scientific journals such as Therapeutic Innovation & Regulatory Science. She is the vice chair of the 2021 DIA Japan Annual Meeting Program Committee. She received DIA Global Inspire Award Connector in 2022. She is teaching at Keio University and Chiba University and is a pharmacist.