Steffen Thirstrup is a medical doctor and board certified specialist in clinical pharmacology and therapeutics. He holds a PhD in pharmacology and has a long background in clinical internal medicine. He is an adjunct professor at the Faculty of Health Sciences, University of Copenhagen. From 2004-9 ST worked at the Danish Medicines Agency acting as member of CHMP and additionally CAT at the European Medicines Agency. Following a short period involved in developing best practice guidelines for primary care ST rejoined the DKMA as Head of the Licensing. From 2013-22, Prof Thirstrup worked asdirector and strategic consultant for NDA Group AB. From June 2022 Prof Thistrup is the Chief Medical Officer of the European Medicines Agency.

Peter Bachmann is acting as the German NtA Member, a Member of the European Union Network Data Board and the EU IDMP/SPOR Task Force, the HMA WG ‘Better Use of Medicines’/'ePI Task Force', the International Pharmaceutical Regulators Programme (IPRP) Management Committee, and the European Lead of the ICH IGDG (Informal Generic Discussion Group). He has studied biology and chemistry and has a PhD in Pharmaceutical Biology, University of Wuerzburg (Germany). Following a JSPS postdoctoral fellowship at Kyoto University and a DFG Fellowship at the Institute of Food Research Norwich/UK, he has worked at the Institute of Pharmaceutical Biology, TU Braunschweig/Germany, until he joined in 1999 the BfArM, Department of Drug Approval.

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).