●Pre-Conference Symposium on Computerized System (GCP)
    Current & Future of Clinical Data Standards -"CDISC Makes You Happy!"
    Mr. Yoshio Tsukada (Japan)

      J3C, GlaxoSmithKline

      Title: "CDISC Makes You Happy!" - Introduction -

    Dr. Rebecca D. Kush (USA)
      President and CEO, Clinical Data Interchange Standards Consortium (CDISC)

      Title: From the Perspective of CDISC Consortium

    Mr. Osamu Komiyama (Japan)

     (Japan Pharmaceutical Manufacturers Association (JPMA), Pfizer Japan)

      Title: To Foster a Discussion on CDISC Standards among Japanese Community

    Mr. Kazumasa Iwamoto (Japan)

      Eli Lilly Japan K.K.

      Title: CDISC – A Way to Streamline Clinical Development

    Mr. Hitoshi Matsui (Japan)

      CAC Corporation

      Title: Clinical Data Standardization the Current & the Future from CRO Perspective

    Prof. Hiroyuki Furukawa (Japan)

      Yamaguchi University Graduate School of Medicine

      Title: From the Perspective of Medical Institution

●Welcome Reception

●Opening Plenary

●Special Lectures
   Mr. Yoshiharu Habu (Professional shogi player)
   Title: Brush Up Your Decision-Making -The Attitude for Selecting the Best Strategy -

   Dr. Andrew Waddell (Ex-Chairman of BARQA, Director of TMQA)
   Title: Effective Continuing Professional Development of QA Staff

●Asian Session (GCP)
    Quality Assurance of Asian Clinical Study Data for the Regulatory Mutual Acceptance among Asian

    Countries and GCP Inspections conducted by Asian Regulatory Authorities. 

    Prof. Shinichi Kawai (Japan)

      Toho University Omori Medical Center

      Title: Is There Any Ethnic Difference in Pharmacokinetics among East Asian Countries?

    Dr. Jong-Pill Park (Korea)

      Director of Clinical Trials Mnagement Division, Risk Prevention Policy Bureau

      Korea Food & Drug Administration (KFDA)

      Title: KFDA Inspection Program and Round Education for Quality of the Clinical Trials

    Dr. Li Jian Ming (China)

      Director, Inspection Division Ⅰ, Centoer for Certification od Drug

      The State Food and Drug Administration (SFDA)

    Ms. Mari Shirotani (Japan)

      Pharmaceuticals and Medical Devices Agency (PMDA)

      Title: GCP Inspections by PMDA

●Asian Session(GLP) : GLP in Asian Countries

    Dr. IL Je Yu (Korea)
      President of Korean Society of Quality Assurance (KSQA)
      Preofessor, Hoseo University

      Title: Current Status and Perspectives of Korean GLP
    Dr. Xigeng Bai (China)
      Vice President of Chinese Society of Quality Assurance (CSQA)
      QAU Manager/ Shenyang Research Institute of Chemical Industry
      Title: Current Status of GLPs in China
    Prof. Tsung-Yun Liu (Taiwan)

      President of Taiwan Society of Quality Assurance (TSQA)

      Professor and Chairman, National Yang-Ming University Institute of Environmental and

      Occupationalo Health Sciences

      Title: The GLP Status in Taiwan
    Dr. Siripan Wongwanich (Thailand)
      Principal Medical Scientist, Department of Medical Sciences, Ministry of Public Health
      Title: The Establishment of GLP Program in Thailand
    Dr. Vinita Sharma (India)
      Head, India National GLP Complaince Monitoring Authority
      Title: GLP Scenario in India
    Dr. Salmaan Inayat-Hussain (Malaysia)
      Dean of Faculity, University Kebangsaan Malaysia

      Title: Road to GLP- compliance: The experience of Melaka Toxicology Laboratory
    Ms. Esther Ee (Singapore)

      Director of Global Center Laboratories, Asia Pacific, PPD Inc.
      Title: Current GLP status in Singapore

    Mr. Yoichi Sato (Japan)

      Pharmaceuticals and Medical Devices Agency (PMDA)

      Title: Japanese National GLP Monitoring Programme on Medical Products

●Concurrent Session GMP/GQP : GMP and/or GQP Regulation, ICH Q Trio Approach Laboratories

    Mr. Daisaku Sato (Japan)

    Ministry of Health, Labour and Welfare (MHLW)

●Concurrent Session GLP (1) : International Interpretation of GLP / GCLP

●Concurrent Session GMP for Investigational Products :

    Quality Assurance on Investigational Products - Interface between GMP and GCP -
    Dr. Andy Tudor (UK)

      Lead QP/QA Director, Pfizer

      Title: Interface between GMP and GCP
    Dr. Shinichi Kodato (Japan)
      Senior Leader, Chugai Pharmaceutical Co., Ltd

      Title: Current Status of Interface between GMP and GCP in Japan

    Mr. Hirofumi Ueda (Japan)
      Office of Compliance and Standards/ Pharmaceuticals and Medical Devices Agency (PMDA)

      Title: GMP Inspection on Investigational Medicinal Products

●Japan Night

●Concurrent Session GCP (1) : Discuss GCP compliance clinical trial from the “risk ”standpoint

    Prof. Masayuki Horie (Japan)

      Nihon University

      Title: Where Are We Going? - What Is the Clinical Trial Risk Management For? -

    Mr. Denis Moulin (Switzerland)

      Vice President of Research and Development Quality Assurance, Merck Serono S.A. Geneva

      Title: Quality Risk Management

               : Development and implementation of a GxP approach
                  - First operational translation
     Ms. MaryEllen Lander (USA)

      Associate Director, Falcon Consulting Group

      Title: How to Establish a Global Quality Assurance System

●Concurrent Session GLP (2) : International Interpretation of GLP

●GLP Special Session :

    The GLP Facility Restoration from the 2011 Great East Japan Earthquake Damage

    Mr. Kaname Takahashi (Japan)

      Mitsubishi Chemical Medience Corporation

●Concurrent Session GLP (3) : The Quality of Bioanalytical Studies

    Dr. C.T. Viswanathan (USA)

      CT Viswanathan & Associates INC

      Title: The Quality of Bioanalytical Studies
    Dr. Samantha Atkinson (UK)

      Senior Inspector,

      Medicines and Healthcare products Regulatory Agency

      Title: UK Guidance on Regulatory Compliance for Clinical Laboratories
    Dr. Yasuo Ohno (Japan)

     Director General/ National Institute of Health Sciences

      Title: Secure Reliability of Data for New Drug Application in Japan - Non GLP Tests -
    Mr. Laurent Bouillot (France)

      President of French Society of Quality Assurance (SoFAQ)

      Quality Site Head, Sanofi

      Title: Which Quality Systems for non GLP studies

    Mr. Stephen B. Rogenthien (USA)

      Ricerca Biosciences

      Title: The Impact of Incurred Sample Reanalysis on Bioanalyses

●Concurrent Session GMP :

    Audit check points on GMP for Investigational products and commercial products
    Mr. John C Mandy (USA), Director, Pfizer

    Mr. Timothy P Reinhardt (USA), Director, Pfizer

      Title: Key check points on GMP audit
    Mr. Hirofumi Ueda (Japan)
      Office of Compliance and Standards/Pharmaceuticals and Medical Devices Agency (PMDA)

      Title: GMP Inspection by PMDA

●Concurrent Session GCP (2) : Quality Control and Quality Assurance in Japan
      - Quality Control and Quality Assurance in the Future (Toward Next Generation) -

    Prof. Hiroe Tsubaki (Japan)

      The Institute of Statistical Mathematics

      Title: Role of Quality Management Principle for Drug Development

    Ms. Cheryl Bissey-Black (USA)

      Senior Consultant, Falcon Consulting Group

      Title: Quality Control Training for Clinical Trial Personnel

    Mr. Peter Elfrink

      Director, GCP Europe & APAC, Research Regulatory Compliance (RRC)

      PAREXEL International

      Title: Conducting and Hosting an International Audit at a CRO in Japan

●Concurrent Session GLP (4) :

    Quality Assurance for Electronic Records in Non-clinical Laboratories

    Mr. Sion Wyn (UK)

      Director, Conformity Ltd
      Title: Data Integrity and Retention - an update on Annex 11 and Part 11
    Ms. Stephanie Taulbee (China)

      Director of Quality Assurance and Regulatory Compliance,

      Pharmaron Preclinical Services Laboratory

      Title: How Validation Changes the Way We Do QC and QA

●Concurrent Session Pharmacovigirance :

    Pharmacovigilance Regulation, Pharmacovigilance Quality Assirance
    Dr. Calvin Johnson (UK)

      Senior Pharmacovigilance Inspector,

      Medicines and Healthcare products Regulatory Agency

      Title: The evolution of pharmacovigilance and pharmacovigilance inspections in the EU

    Ms. Grace M Crawford (USA)

      Sr. Director, QA, ICON Clinical Research

      Title: Regulated Pharmacovigilance Systems

              - How to Ensure Quality to meet FDA Expectations

    Dr. Daisuke Tanaka (Japan)

       Ministry of Health, Labour and Welfare (MHLW)

      Title: Better Safety for Medicinal Products - Pharamacovigilance in Japan -

●GMP Auditor Training (Basic course)
    Provide an interactive auditor training on basic and important points on GMP audit
     by trainers in worldwide audit group of a global pharmaceutical company.

    Mr. John C Mandy (USA), Director, Pfizer

    Mr. Timothy P Reinhardt (USA), Director, Pfizer

      Title: GMP (IP-GMP) Quality Auditor Training