Essential Project Leadership in Navigating an Evolving Regulatory Landscape in Asia-Pacific
Hwee Hwee Tey
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.
The Regulatory Landscape and Development Pathways of Regenerative Medicine and Orphan Drugs in Japan
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