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Monday, June 25 • 3:00pm - 4:00pm
#148: Essential Project Leadership in Navigating an Evolving Regulatory Landscape in Asia-Pacific

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Component Type: Session
Level: Intermediate
CE: CME 1.00; IACET 1.00; PDU 1.00 PMI 2166-000221; RN 1.00

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 Objectives

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.


Hwee Hwee Tey


Balancing Unity and Individuality: Leadership Skills for Managing Culturally Divergent Clinical Teams
Brian Malkin, JD

The Regulatory Landscape and Development Pathways of Regenerative Medicine and Orphan Drugs in Japan
Gregg Mayer, PhD

Including the APAC Region into a Global Study:An Operational Perspective
Winnie Lim, MSc


Winnie Lim

Manager Clinical Operations - Asia, Aurinia Pharmaceuticals Inc.
Early in her career, Winnie worked in a translational research facility in the discovery of genetic biomarkers. She developed an interest for and transitioned into, clinical development and operations and has been working in the industry for the last 6 years gaining experience in... Read More →
avatar for Brian Malkin

Brian Malkin

Counsel, Arent Fox LLP
Brian has more than 24 years of food and drug law practice and over 13 years of intellectual property law practice. In particular, his practice includes the interrelation between patent law and food and drug law. Brian's regulatory experience includes all types of FDA-regulated products... Read More →
avatar for Gregg Mayer

Gregg Mayer

President, Gregg L. Mayer Company, Inc.
Gregg received his BA and PhD from the University of California, Berkeley. After serving as President at Berkeley Antibody Company, and Vivigen, Inc., Gregg studied at Keio University in Tokyo. He then joined the San Francisco office of McKinsey & Company, later leaving to establish... Read More →

Hwee Hwee Tey

Head of Project Management & Regulatory Affairs, CMIC Asia-Pacific, Pte. Ltd.
HweeHwee is the Head of Project Management & Regulatory Affairs in CMIC APAC Services & is also responsible for the Company’s clinical operations within Southeast Asia. HweeHwee holds a bachelor’s degree in Microbiology from National University of Singapore. Following her clinical... Read More →

Monday June 25, 2018 3:00pm - 4:00pm EDT
Room 258C Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  07: ProjMgt-StrategicPlanning, Session