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How to Make a Strategic Partnership Model Work at the Country/Site Level in Asia Pacific and Insight from a Regulatory Inspector
Session Chair(s)
Catherine Lee, MBA, MPharm, MSc
Area Head-Asia, Clinical Trial Support and Compliance
Pfizer Inc, Taiwan
Many pharmaceutical companies are building partnerships with contract research organizations (CROs). However, there are many obstacles at the country level. In this session, we will discuss how to establish the CRO/sponsor partnership in Asia. The insight of a regulatory inspector will also be shared.
Learning Objective : Recognize the challenges and opportunities in running global trials in Asia Pacific under a strategic partnership model between a contract research organization (CRO) and sponsor; Share best practices regarding the partnership to drive project delivery in Asia Pacific countries; Discuss the impact of CRO inspection results in Taiwan through the insight of a regulatory inspector about CRO/sponsor partnerships.
Speaker(s)
Sharing Best Practices on What the True Partnership Looks Like to Drive Project Delivery in Asia Pacific Countries (from Sponsor Perspectives)
Catherine Lee, MBA, MPharm, MSc
Pfizer Inc, Taiwan
Area Head-Asia, Clinical Trial Support and Compliance
Sharing Best Practices on What the True Partnership Looks Like to Drive Project Delivery in Asia Pacific Countries (from CRO Perspectives)
Lydia Paul, PMP
PAREXEL International, Malaysia
Associate Director, Project Leadership
Impact of CRO Inspection Results in Taiwan: Insight from a Regulatory Inspector About CRO/Sponsor Partnerships
Wen-Ting (Mandy) Liu
Center for Drug Evaluation (CDE), Taiwan
Team Leader of GCP Inspection Team
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