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9th DIA FDA IND/NDA Training Course in Japan

All prices are exclusive of 10% Japanese consumption tax

Faculty

  • Carol H. Danielson, DrPH, MS, RAC

    Carol H. Danielson, DrPH, MS, RAC

    • President
    • 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

    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.

  • Masayoshi  Higuchi

    Masayoshi Higuchi

    • 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

    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.

  • Yumi  Inukai

    Yumi Inukai

    • New Drug Regulatory Affairs Dept.
    • Daiichi Sankyo Co., Ltd., Japan

  • Miyuki  Kaneko

    Miyuki Kaneko

    • 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

    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.

  • Miwa  Tamada

    Miwa Tamada

    • Manager, New Drug RA Department, Regulatory Affairs
    • GlaxoSmithKline K.K., Japan

Contact us

Please contact the DIA Japan office in Tokyo for further information.

Tel: +81-3-6214-0574
Fax: +81-3-3278-1313
Japan@DIAglobal.org
www.diajapan.org