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DIA 2018 Global Annual Meeting

The DIA 2018 Global Annual Meeting brings together thousands of innovators from around the globe.

Essential Project Leadership in Navigating an Evolving Regulatory Landscape in Asia-Pacific

    Session Chair(s)
      Hwee Hwee  Tey

      Hwee Hwee Tey

      • Associate Director
      • CMIC Asia-Pacific, Pte. Ltd., Singapore
    Regulatory agencies in Asia-Pacific region are taking various initiatives and proactive approaches to promote global drug development to the industries. Such initiatives are supported by recent changes in regulatory requirements resulting an increased number of Asian-based biopharmaceutical and biotechnology companies planning and conducting clinical trials that involved countries in the North America, Europe and Asia-Pacific, in addition to country of origin in Asia. Despite there are many global and local CROs accessible by sponsors in different countries and regions, one common challenge encountered lies with the proficiency of project leadership competencies in that such competencies are directly and indirectly determining the success and failure of a project from planning to smooth execution.
    This session will outline changes of regulatory landscape and requirements in representing developed and developing markets : (1) Japan (regenerative medicine and orphan drug development)
    (2) Southeast Asia (regulatory changes in clinical trial review and approval).
    Core elements of project leadership competencies that must have in effective project management will be covered in the presentations which will benefit to attendees.
    Learning Objective : Discuss the changes of regulatory landscape and requirements in selection countries in Asia-Pacific region; Describe the challenges encountered in the project planning and management under an evolving regulatory landscape; Identify core project leadership competencies must have in an effective project management.
      Gregg  Mayer, PhD

      The Regulatory Landscape and Development Pathways of Regenerative Medicine and Orphan Drugs in Japan

      Gregg Mayer, PhD

      • President
      • Gregg L. Mayer Company, Inc., United States
      Phoevos  Hughes, PhD

      Balancing Unity and Individuality: Leadership Skills for Managing Culturally Divergent Clinical Teams

      Phoevos Hughes, PhD

      • Regional Director, Project Management- Asia
      • Biorasi, United States
      Winnie  Lim, MSc

      Including the APAC Region into a Global Study:An Operational Perspective

      Winnie Lim, MSc

      • Manager Clinical Operations - Asia
      • Aurinia Pharmaceuticals Inc. , Canada