Ms. Ellen Ying-Hua Chen is the Deputy Director of the Quality Compliance and Management Division (GXP Inspectorate) at the Taiwan Food and Drug Administration (TFDA). In this role, she oversees GMP/GDP compliance for medicinal products, QMS compliance for medical devices, Good Tissue Practice compliance for cell/tissue-based products and tissue/cell banking, GLP compliance for testing facilities, as well as international cooperation in GMP/GDP for medicinal products.

 

Ellen has been working in the GXP inspectorate over 18 years after receiving an MBA in Technology & Innovation Management from National Cheng-Chi University in Taiwan. Before that, she graduated from Pharmacy School of Taipei Medical University in 1999; then, worked as a laboratory specialist for about 3 years. 

 

Ellen is actively involved in international harmonization activities and has extensive experience with the Pharmaceutical Inspection Co-operation Scheme (PIC/S). She represents TFDA in PIC/S and has served on the PIC/S Executive Bureau through her chairmanship of the PIC/S Sub-Committee on GMDP Harmonization for term 2024-2025.