9th DIA FDA IND/NDA Training Course in Japan
Carol H. Danielson, DrPH, MS, RAC
- Regulatory Advantage, LLC, United States
Ms Carol H. Danielson, Dr PH, RAC has provided regulatory expertise and leadership for more than twenty five years for drugs, biologics and medical devices from discovery through post-marketing. Her areas of specialization include regulatory strategy and submissions, clinical affairs and compliance, and quality assurance and control. Her background includes both extensive “hands on” experience and corporate level strategy activities from partnering due diligence to serving as an expert witness in the drug development process.
Alberto Grignolo, PhD
- Corporate Vice President
- Parexel, United States
Alberto Grignolo, PhD is a Corporate Vice President at Parexel, and established the firm's Japan Consulting Services during a two-year assignment in Tokyo. Dr. Grignolo has served as an adviser on human subject protection in clinical trials to the Institute of Medicine of the National Academy of Sciences, on the first Executive Committee of the Clinical Trials Transformation Initiative, as Chairman of the Regulatory Affairs Professional Society, and as President of FIDIA Pharmaceutical Corporation. He is a DIA Fellow, Editor-in-Chief of DIA's digital magazine Global Forum, and serves on the faculty of DIA's Regulatory Affairs: The IND, NDA, and Post-Marketing training course, which he has taught in Japan, China, Korea, Europe, and the US.
- Head of Quality & Regulatory Compliance Unit,
- 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
- Associate Director, Regulatory Development Dept., Regulatory Affairs 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