Dr. Steffen Thirstrup, MD, PhD, has been Chief Medical Officer at the European Medicines Agency (EMA) since June 2022. A specialist in clinical pharmacology, he has held leadership roles at the Danish Medicines Agency, served as a CHMP member at EMA, and co-chaired the European Commission’s biosimilar market access group. An adjunct professor at the University of Copenhagen, Dr. Thirstrup has authored over 40 publications and co-edited a key Danish pharmacology textbook. He divides his time between Amsterdam and Værløse, Denmark.

Dr. Peter Bachmann is a senior regulatory scientist with over 25 years of leadership at the Federal Institute for Drugs and Medical Devices (BfArM) in Germany and deep expertise in EU and global regulatory harmonization. He served as Chair of CMDh, Member of the EMA Scientific Coordination Board, EU Network Data Board, and HMA, representing the EU in ICH and as Chair of IPRP. Currently a Board Member of DGRA, he holds a Ph.D. in Pharmaceutical Biology from the University of Würzburg and completed postdoctoral research in Japan and the UK. He lectures at the Universities of Bonn, Basel, and Copenhagen, and has received TOPRA Lifetime Membership, MEGRA Honorable Membership, DIA Fellowship, and the DIA Outstanding Contribution to Health Award

Education Background: Graduated Tokyo University of Pharmacy and Life Sciences / Qualification: Licensed Pharmacist / CURRENT POSITION: Senior Manager of Policy Intelligence Department in Janssen Pharma K.K (Japan), A leader of Regulatory Sub Committee in PhRMA Japan, A member of Contents Committee in DIA Japan / SUMMARY OF PROFESSIONAL EXPERIENCE: 5 years of experiences at regulatory policy and intelligence; About 20 years of experiences at regulatory affair area including development for New drugs (NDA/ PMDA consultation); Started the carrier at Sankyo Co. (Currently Daiichi-Sankyo Co.) in 1986.

Mr. Masayoshi Higuchi is a vice president and the head of Quality & Regulatory Compliance Unit at Chugai Pharmaceutical Co Ltd. He has over 30 years of experiences; including 2 years’ regulatory works at Roche in Basel, Switzerland. His areas of specialization include small molecular, biologics and medical devices from discovery, development, manufacturing, and to post-marketing. He was a member of the Japan Pharmaceutical Manufacturers Association (JPMA), the European Federation of Pharmaceutical Industries and Associations (EFPIA), the Federation of Pharmaceutical Manufacturers' Associations of JAPAN, FPMAJ and other industrial associations during his career.He has also contributed to Drug Information Association (DIA) since 2014.

Japan Regulatory Portfolio Lead, Regulatory Strategy Group 3, Regulatory Strategy & Policy, Regulatory Affairs, Pfizer Japan Inc. Biography: I have worked for Pfizer since 2003. As a Japan Regulatory Lead, I worked on drug development (NDA/ PMDA consultation). I currently work on development drugs in Inflammation, Pain, CNS and Endocrinology as a Japan Regulatory Portfolio Lead. I received my bachelor and master degree in Pharmaceutical Science from Fukuoka University.

Mr. Matsuoka is Senior Director of Pharmacovigulance Department at Daiichi Sankyo Co., LTD. He joined Sankyo Co., LTD. in 1991, and has worked for Daiichi Sankyo Co., LTD.since 2007. After engagement in clinical development department and regulatory affairs department for over 20 years, and moved to pharmacovigilancedepartment. Currently, he is in charge of safety planning for the several therapeutic areas such as CV, oncology, CNS, vaccines and contrast agents.

Hiromi Okabe earned a PhD in Pharmaceutical Sciences in 2004. Whilst in graduate school, she was a research fellow at the Japan Society for the Promotion of Science (DC2). Dr. Okabe started her career at Daiichi Pharmaceutical Co.,Ltd. (currently Daiichi Sankyo Co.,Ltd.) in 2004. After she engaged in clinical pharmacology department, she expanded her interests to regulatory, and joined regulatory affairs department in 2015. Apart from her role in Daiichi Sankyo, she has served as DIA Japan Operation Team member from 2015 to 2017 and its leader since 2016 and contributed many programs, e.g. DIA Japan Annual Meetings and some training courses. She is also a program committee member of 2nd DIA Cell Therapy Products Symposium in Japan (2017).