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.

Hyang Won (Harriet) MIN is currently Vice President, Head of Regulatory Affairs Asia Pacific, Johnson & Johnson Innovative Medicine since 2022, based in Singapore. Harriet has diverse and extensive pharmaceutical and medical device industry experiences over 25 years. she started her industry career as a Medical Information Specialist at MSD Korea in 1999 and soon transitioned into roles in Regulatory Affairs. Over the years, she has grown into an expert regulatory affairs professional, while expanding her leadership roles in various functions including Pharmacovigilance, Market Access, Quality Assurance, and Medical Affairs at MSD Korea, UCB Korea, GE Healthcare Korea, and Janssen Korea.

Seong Eun Moon is the Deputy director, Office of Pharmaceutical Safety Evaluation division, Department of Pharmaceutical Safety Bureau, Ministry of Food and Safety (MFDS), Republic of Korea. SeongEun Moon joined the Ministry of Food and Drug Safety(MFDS) in 2006, and is currently involved in implementation of RMP and re-evaluation system. She has worked in different positions of MFDS including development of pharmaceutical policy in pharmacovigilance field.

Mark A. Collins is the Head of Global Labeling at CSL Behring, a global biotherapeutics leader. He was previously the Senior Director, Risk Management & Global Labeling Advisor at Endo Pharmaceuticals in Malvern, PA. Mark’s professional experience includes project management, Labeling, REMS (Risk Evaluation and Mitigation Strategy) programs, and surveillance and epidemiology programs. Mark received his BSc and PhD degrees in chemistry from the University of Sheffield in the UK and an MBA from Eastern University in St Davids, PA.

President of Pharmiceutics LLC, a consulting firm based in Pennsylvania, USA. Pharmiceutics offers consulting, training and services for labeling. Before founding Pharmiceutics in 2005, Leander served as Vice President and Head of Global Labeling Division and Vice President, International Labeling Liaison, for Wyeth, USA. He started his career in global labeling in 1991 and has served as head of global labeling functions for Hoechst (Germany) and Hoechst Marion Roussel (USA). He has also held positions in clinical development and clinical pharmacology with Behringwerke (Germany). Before joining the pharmaceutical industry, he worked as a physician in internal medicine as well as in anesthesiology, intensive care and emergency medicine.

E. Stewart Geary, MD, is Global Safety Officer at Eisai Co., Ltd. He is a Councilor of the Japanese Association of Pharmaceutical Medicine and serves on the Editorial Advisory Board for the Journal of Pharmaceutical Medicine. A member of CIOMS XII, he also served on the CIOMS VII Working Group on the Development Safety Update Report, CIOMS VIII on Signal Detection, CIOMS on Standardized MedDRA Queries, CIOMS IX on Medicinal Product Risk Management and CIOMS Working Group on Drug-Induced Liver Injury. Dr. Geary is a DIA Fellow, a Fellow of the Academy of Physicians in Clinical Research and an IFAPP Global Fellow in Medicines Development. He earned a BA from Harvard and MD from Stanford Medical School.

YeunKum Lee is the Deputy General Manager of the Pharmacoepidemiology and Big Data Analytics office at (Korea Institute of Drug Safety and Risk management), Republic of Korea. She is currently investigating the regulatory affairs and the safety issues about ATMPs (Advanced Therapy Medicinal Products) in Korea, as well as in foreign countries. She also established a Pharmaco-epidemiologic safety management system for ATMPs. She received her Ph.D. from Georgetown University, Department of Pharmacology, and Bachelor’s degree from Ewha Womans University, College of Pharmacy.

Dr. Ju-Young Shin is current chair professor of department of biohealth regulatory science at school of pharmacy, SungKyunKwan University (SKKU). She also serves as an associate editor of SCIE journal including ‘Pharmacoepidemiolgoy and Drug Safety’, and ‘Epidemiology and Health’. She received her B.S. in pharmacy from Seoul National University, MPH in health policy and Ph.D. in pharmacoepidemiology from the Seoul National University College of Medicine. She was working as a director at Korea Institute of Drug Safety and Risk Management (KIDS), university of South Australia as a visiting fellow and McGill University as a postdoctoral fellow.

He received formal training in infectious diseases and molecular mechanisms of pathogenesis and has more than 15 years of experience directing global product development and registration programs. He also has extensive experience in pharmacovigilance and health informatics as well as the evaluation and exchange of safety data. He has served with other experts and senior scientists on many consensus panels, including ICH, CIOMS, ISO, and HL7.

Mireille Muller Ph.D. has over 25 years of experience in regulatory affairs at the global level, including policy, benefit-risk research, drug development focused in clinical research. Special interest in early development, scientific advice, expedited regulatory pathways, and innovative clinical trials such as innovative clinical trial designs, decentralised trials and digital health systems. Involved in several public private partnerships IHI/IMI programs and pre-competitive collaboration.

Dr. Große-Michaelis is a clinical pharmacologist trained in internal medicine and pharmacology/ toxicology with a longstanding interest in the risk-benefit profile of drugs, and drug development. She obtained her medical degree from the Humboldt University of Berlin, Germany. The Robert-Koch-Award was granted for research in the neonatal field. She was heading several clinical drug development projects in the pharmaceutical industry before she became interested in data retrieval and analysis. Currently she is a Senior Medical Dictionary Expert responsible for medical coding of AEs and creating of home grown groupings. She represents Bayer at CIOMS.

Ayano Kobayashi is a reviewer of the Office of Safety ?, Pharmaceuticals and Medical Devices Agency (PMDA) and served as a risk manager of oncology drugs since 2019. She joined PMDA in 2009 and served as a reviewer in the Office of New Drugs ?(Cardiovascular drugs).

Jan is a passionate and visionary leader in the field of pharmacovigilance, with over 20 years of experience in the industry. He is the CEO of iVigee, a company that provides innovative and sustainable solutions for drug safety and risk management. He is also a Fellow of the International Society of Pharmacovigilance (FISoP), a Global Fellow in Medicines Development (GFMD), and a Qualified Person for Pharmacovigilance (QPPV). Jan has a proven track record of establishing, growing, and selling successful organizations, both for-profit and non-profit, in the pharmacovigilance sector. He has received multiple awards and recognitions, including the DIA Excellence in Service Award in 2018 and HM Queen's Award for International Trade in 2019.