Chia-Hua (Maggie) Ho has over 15 years of experience in clinical research and pharmaceutical product development. She is responsible for the management of Amarex Taiwan, an NSF International company, including APAC regulatory submission, clinical operations, business development and client services for the Pan-Pacific region. Dr. Ho creates regulatory approval strategies for small molecule drugs, biologics, botanicals and devices in a wide range of therapeutic indications for product development in the U.S. and Asia.
Her areas of expertise include:
- U.S. FDA/TFDA/NMPA regulation and approval strategies
- Multi-regional clinical trials (MRCTs)
- Good Manufacturing Practices (GMPs)
- Quality system regulations (QSRs)
- Artificial intelligence (AI) software and software as medical device (SaMD)