Heidi Liu, M.D
Quality Assurance, Global Lead, China
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8 years of industry experience with J&J, Pfizer and GSK in clinical quality planning and strategy, quality risk management and GCP audit
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3 years of research institution experience with Shanghai HuaShan Hospital and Peking University in Human Research Protection Program
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3 years at Forum for Ethical Review Committee in Asia and the Western Pacific Region (FERCAP) in ethics committee recognition program
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5 years as clinical monitor & auditor for WHO TDR clinical research projects
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7 years as General Physician at Shanghai Zhongshan Hospital
Specialties
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Quality Risk Management & Quality by Design
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Process analysis and re-engineering
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Clinical Trial Management & Monitoring
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IRB/IEC Operation Process
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GCP Audit & Issue Management
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SOP Development & Management
Experience
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Quality Risk Management in Clinical Trials – strategy, concept, methodology, process and implementation
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Lead identification, escalation, investigation and resolution of quality/compliance issues
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Leverage quality analytics data, internal and external factors and contextualized key quality insights to provide quality consultancy
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Established quality oversight process for Patient Assistant Program
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Conducted GCP audit at investigation sites and vendors in AP region
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Conducted survey activities according to WHO “Surveying and Evaluating Ethical Review Practice” Guideline for ethics committee recognition in China, Thailand, South Korea, Philippine
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Developed and implemented Human Research Protection Program
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Trainer on standard course on “Research Ethics and Good Clinical Practice” and “Standard Operational Procedures of Ethics Committee”