5th DIA European Medicines Regulations Training Course
- Deputy-Head, European Union and International Affairs
- Federal Institute for Drugs and Medical Devices (BfArM), Germany
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.
Steffen Thirstrup, MD, PhD
- Director, NDA Regulatory Advisory Board
- NDA Advisory Services Ltd, United Kingdom
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 in pharmacotherapy at the Faculty of Health Sciences, University of Copenhagen. From 2004-9 ST worked at the Danish Medicines Agency (DKMA) acting as the Danish 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 Division. In March 2013 Prof Thirstrup joined NDA Group where currently is the director of Regulatory Advisory Board at NDA Regulatory Services Ltd.
- Department Manager, Business Strategy & Compliance Department
- Chugai Pharmaceutical Co., Ltd., Japan
Mr. Masayoshi HIGUCHI is the head of regulatory affairs department at Chugai Pharmaceutical Co., Ltd. He has 26 years’ experience of regulatory affairs, covering both regulatory strategy and operation, from early development stage to post-marketing authorization & maintenance phases. He also worked in Europe for 2 years, and has been contributing to industrial organizations and associations, e.g. EFPIA Japan, JPMA, ICH and DIA.
Akiko Ikeda, RPh
- Senior Manager, Policy Intelligence Dept., Integrated Market Access Division
- Janssen Pharmaceutical K.K., Japan
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.
- New Drug Regulatory Affairs Dept.
- Daiichi Sankyo Co., Ltd., Japan
- Japan Regulatory Portfolio Lead, Regulatory Affairs
- Pfizer R&D Japan, Japan
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.
Yomei Matsuoka, MSc, RPh
- Vice President, Pharmacoepidemiology and PMS Department
- Daiichi Sankyo Co., Ltd., Japan
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.
- Manager, New Drug RA Department, Regulatory Affairs
- GlaxoSmithKline K.K., Japan