EU ATMPs Quality Regulation

  Рет қаралды 183

ISPE Singapore Affiliate

ISPE Singapore Affiliate

9 ай бұрын

10 Oct 2023
5.30-6.30pm SGT | Online
Led by:
Ang Wei Xia, APAC Regulatory Compliance Leader, Cytiva
Ang Wei Xia is currently based in Cytiva Singapore as a Regulatory Compliance Leader. She collaborates with other functional teams within Cytiva to ensure that all Cytiva products adhere to the respective countries' regulatory requirements.
Prior to joining Cytiva, Wei Xia worked in various A*STAR institutes as a researcher. During her Ph.D. years, her research focused on Chimeric Antigen Receptor (CAR) T-cell cancer immunotherapies.
Subsequently, Wei Xia transitioned to the Health Sciences Authority of Singapore, where she served as a drug regulator. In this role, Wei Xia reviewed clinical and quality dossiers submitted for clinical trials applications, encompassing therapeutic products, medicinal products, as well as Cell and Gene therapy products. She also assessed quality dossiers for marketing authorization and provided scientific and regulatory consultations to companies to support the development of therapeutic products and cell, tissue, or gene therapy products.
Later on, Wei Xia moved to a clinical-stage US biotechnology company called Hummingbird Bioscience, specializing in antibody drugs. In this position, she was responsible for devising, executing, and managing international regulatory strategies and medicinal authorization submissions.

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