Hui Talia Z.
Clinical and Safety
About
Senior executive with global experience handling safety, clinical development, medical, regulatory, and quality issues. Former regulator at the U.S. FDA. Experience and knowledge in IND, NDA, MAA submissions and Health Authority interactions. Expert knowledge of inspections and global safety regulations – FDA, EU GVP, ICH guidelines, etc. Strong technical and problem-solving skills with strategic decision-making abilities.
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United States
Pharmaceuticals
Matrix Management, GVP, drug induced liver injury, Molecular & Cellular Biology, New Drug Application (NDA), Investigational New Drug Application (IND), Regulatory Approvals, Cross-functional Team Leadership, Clinical Monitoring, Epidemiology, Adverse Event Reporting, Safety Regulations, Neuroscience, Prostate Cancer, Regulatory Compliance, Cancer Therapeutics, Cancer Research, Regulatory Labeling, Lymphoma, Real World Data (RWD)
Experience
Clinical and Safety
NesebAI
Chief Medical Officer & Head of Patient Safety and Epidemiology
Emergent BioSolutions
VP and Global Head, Oncology Benefit Risk and Patient Safety
Bayer
Education
Harvard University
Cancer Research
Hui Talia Z.'s Contact Information
Phone
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