Detailed Program Information   Updated: October 29, 2011

    Please download the PDF files below for the latest 3rd GQAC programs.

    Oral Sessions                   Meeting with PC operator

    Poster Sessions                Poster Presentation instruction

Program At a Glance   Updated: October 29, 2011

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Sessions Outline   Updated: September 24, 2011

    To download the Sessuions Outline, please click here


Invited speakers   Updated: October 29, 2011

November 13 (Sun)


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

November 14 (Mon)


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

November 15 (Tue)


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

November 16 (Wed)


USA/EU/Japan Session (GCP) :

    Quality Assurance of Multinational Clinical Studies for Simultaneous NDA Submissions in the three

     ICH regions

    Ms. Ann Meeker-O’Connell (USA)

      GRCP, Acting Associate Director, Risk Science, Intelligence and Priorization
      U.S. Food & Drug Administration

      Title: CDER Perspective: Building Quality into Clinical Trial Design, Conduct, and Oversight

    Dr. Gunnar Danielsson (Sweden)

      Senior Expert, Pharmaceutical Inspector, The Medical Products Agency (MPA)

      Title: EMA Perspective: The Path Forward

    Ms. Emiko Kondo (Japan)

      Pharmaceuticals and Medical Devices Agency (PMDA)

      Title: PMDA’s Approach to Ensure Quality of Clinical Trials

    Mr. Barney Horne (UK)

      Executive Director Quality Assurance Europe, CQA, PPD

      Title: Planning and Implementing Effective Quality Assurance for Global Clinical Trials

    Ms. Rita Hattemer-Apostel (Switzerland)

      CEO, Verdandi AG

      Title: QA Strategies for Global Clinical Trials – Points to Consider to Succeed in

               International Marketing Authorization Applications



USA/EU/Japan Session (GLP) : International Perspective of Pathology Peer Review

    Dr. C.T. Viswanathan (USA)

      CT Viswanathan & Associates INC

      Title: Pathology Peer Review-A Hybrid Perspective
    Dr. Samantha Atkinson (UK)

      Senior Inspector,

      Medicines and Healthcare products Regulatory Agency

      Title: UK Perspective - Pathology Peer Review

    Dr. Jeffery A. Engelhardt (USA)

      Experimental Pathology Laboratories

      Title: The Practice of Pathology Peer Review: A Pathologist’s Perspective

    Dr. Toshihiko Asano (Japan)

      Pharmaceuticals and Medical Devices Agency (PMDA)

      Title: PMDA's Viewpoint on Pathology Peer Review

   Additional Panelists;

    Mr. Roger Chapman (UK)

      FRQA, Director of Quality Assurance, Huntingdon Life Sciences

    Dr. Munehiro Teranishi (Japan)



SQA/BARQA/JSQA Joint Symposium (GLP/GCP)

    Mr. James A. Ault (USA)

      President of SQA

      Title: Looking Forward – What Does the Future Hold for Quality Assurance?
    Ms. Rachel Hodges (UK)

      Chairman of BARQA
      Action Head of Research Quality Management UK, AstraZeneca

      Title: Towards the Next Generation – GLP QA
    Dr. Akira Takanaka (Japan)

      President of JSQA

      Title: What Stance Should JSQA Take for Quality Assurance of the Next Generation?


   Additional Panelists;

    Dr. Andrew Waddell

      Ex-Chairman of BARQA, Director of TMQA

    Ms. MaryEllen Lander (USA)

      Associate Director, Falcon Consulting Group

    Dr. Tatsuya Kondo (Japan)

      Chief Exective, PMDA


Closing Ceremony


Kyoto Short Excursion