About FDA

May 9-11, 2012 — NCTR Global Summit on Regulatory Science in Hangzhou, China

Presentation Topics
Organizing Committee
Keynote Speakers
Global Regulatory Science Board

Summit Theme: Modernizing Toxicology

Presentation Topics:

  • Welcome and Introductory Remarks (PDF version of slides)
  • Modernizing Toxicology - 21st Century Approaches to Address 21st Century Issues (PDF version of slides)
  • Research Training as a Tool to Build Regulatory Capacity (PDF version of slides)
  • Reagan-Udall Foundation for the FDA (PDF version of slides)
  • An Experience with FDA's International Scientists Exchange Program (ISEP) in NCTR (PDF version of slides)
  • Translating Pharmacogenetics/Pharmacogenomics to Personalized Medicine (PDF version of slides)
  • Toxicogenomics in the Land of Regulation - A European Perspective (PDF version of slides)
  • Korean Effort on Modernizing Regulatory Science
  • High Throughput Next Generation Sequencing Technology and Vaccine Quality Monitoring
  • The Japanese Toxicogenomics Project: Collaborative Efforts on Developing Open TG-GATEs Database and Creation of Toxicogenomics Biomarkers
  • A European Perspective on Traditional Herbal Medicinal Products
  • Toxicological Research on Biopharmaceutical in the Past 10 Years in NCSED
  • Toxicology in India: Current Status and Challenges
  • Regulatory Aspect on Non-Clinical Safety Assessment of the Development of New Herbal Medicine and Traditional Chinese Medicine
  • Modernization and Harmonization of Toxicology; An Approach by Percellone Toxicogenomics
  • Data Common and Sharing — A Path Towards Advancing Biomedical Science
  • Role of Chemometrics in Moving Regulatory Science into the 21st Century
  • Role of Epigenetic Change as a Biomarker for Cancer Prediction - An International Collaboration
  • Regulatory Science in Latin America
  • Egyptian Herbal Medicines: An Overview and Recent Applications

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Organizing Committee

  • William Slikker, Jr., Ph.D., Director, National Center for Toxicological Research (NCTR), U.S. FDA 
  • Mary Lou Valdez, Associate Commissioner for Int'l Programs, Office of the Commissioner, U.S. FDA
  • Weida Tong, Ph.D., Director of Center for Bioinformatics, NCTR, U.S. FDA
  • Yiyu Cheng, Zhejiang University, China
  • Fucheng Zhou, Vice Chair, Pharmacopeia Commission of China

Conference and Scientific Liaison:

Weida Tong, Ph.D.
Director of Center for Bioinformatics
U.S. FDA/NCTR/Division of Systems Biology
3900 NCTR Road
Jefferson, AR 72079-9502
E-mail: weida.tong@fda.hhs.gov

Local Contact:

Xiaohui Fan, Ph.D.
Pharmaceutical Informatics Institute
School of Pharmaceutical Sciences
Zhejiang University (ZiJinGang Campus)
Hangzhou, China 310058
E-mail: fanxh@zju.edu.cn; xiaohuifan@gmail.com
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Keynote Speakers:

  • Jun Kanno, Ph.D., Head, Division of Cellular and Molecular Toxicology, National Institute of Health Sciences, Tokyo, Japan
  • Werner Knöss, Ph.D., Head, Department Complementary and Alternative Medicines and Traditional Medicines, Federal Institute for Drugs and Medical Devices, Germany
  • William Slikker, Jr., Ph.D., Director, National Center for Toxicological Research, U.S. FDA

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Global Regulatory-Science Board:

A Board of Directors will be chartered to assemble a global coalition of regulatory-science researchers dedicated to building and strengthening the regulatory-research capacity to insure product safety around the globe.  This virtual community of experts will engage scientists in academia, industry, and government to enhance the integration and application of emerging technologies into the regulatory-research paradigm; foster collaboration and harmonization of education, research tools, and new technologies; and build the global scientific infrastructure needed to advance and promote regulatory science.

Confirmed Board Members:
  • Louis W. Chang, Ph.D., Visiting Chair Professor of Toxicology, College of Pharmacy, Kaohsiung Medical University, Taiwan
  • Yiyu Cheng, Ph.D., Zhejiang University, China
  • Soon Young Han, Ph.D., Director of Toxicological Evaluation and Research Department, National Institute of Food and Drug Safety Evaluation, Korea Food and Drug Administration, Korea
  • Jun Kanno, M.D., Ph.D., Head of Division of Cellular & Molecular Toxicology, Biological Safety Research Center, National Institute of Health Sciences, Japan
  • Jos Kleinjans, Ph.D., Director of Netherlands Toxicogenomics Centre, University of Maastricht, The Netherlands
  • Werner Knöss, Ph.D., Head, Department of Complementary and Alternative Medicines and Traditional Medicines, Federal Institute for Drugs and Medical Devices, Germany
  • Jih-Heng Li, Ph.D., Professor and Dean, College of Pharmacy, Kaohsiug Medical University, Taiwan
  • Changxiao Liu, Ph.D., Academicians of the Chinese Academy of Engineering, Tianjin Institute of Pharmaceutical Research, China
  • Margaret A. Miller, Ph.D., Associate Director for Regulatory Activities, FDA/National Center for Toxicological Research, United States
  • Hala El Miniawy, Professor of Veterinary Pathology, Cairo University, Egypt
  • Prahlad K. Seth, Ph.D., Chief Executive Officer, Biotech Park, Sector G, Jankipuram, India
  • William Slikker, Jr., Ph.D., Director, FDA/National Center for Toxicological Research, United States
  • Weida Tong, Ph.D., Director of Center for Bioinformatics, FDA/National Center for Toxicological Research, United States
  • Mary Lou Valdez, Associate Commissioner for International Programs, FDA/Office of the Commissioner, United States
  • Braulio Jimenez-Velez, University of Puerto Rico, San Juan Puerto Rico
  • Shengli Yang, Ph.D., Director, Division of Medicine and Health Sciences, Chinese Academy of Engineering, Shanghai, China

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