Special Offer: Get 50% off your first 2 months when you do one of the following
Personalized offer codes will be given in each session
Name
Dr Stephen Hsu
Title
Drug and Biologics Consultant | ARQon (Asia Regulatory and Quality Consultancy)
Bio
Stephen has a Bachelor's degree in Molecular Cell Biology from U.C. Berkeley and a Ph.D. in Molecular Genetics and Cellular Biology from the University of Chicago.Companies - From a published scientist in advanced cancer research, Stephen transitioned to industry by first joining the Singapore's Health Sciences Authority reviewing both clinical and quality dossiers of biologics and chemical NDAs. With advances in new therapeutic products, he led the workgroup to consolidate the legal and regulatory framework for cell- and tissue-based therapies. He was also the editor of the local Drug Registration Guideline. At GSK Vaccines' first greenfield, primary biologics manufacturing site outside of Europe, Stephen headed the quality systems team, helping to deliver the first GMP certification from EMA and HSA 2 years after commissioning. As Quality Assurance Head in Novartis Singapore Pte Ltd, Stephen had comprehensive oversight to streamline, remediate, and improve all GxP-impacted processes. Since 2014, Stephen oversees commercial and CMO activities across ASEAN and APAC region in global pharma MNCs.
