Amarex Clinical Research, LLC is pleased to announce that Amarex Taiwan’s COO, Dr. Chia-Hua Maggie Ho, will keynote at the 2019 Taiwan Food and Drug Administration (TFDA) Seminar for Pre-marketing Regulatory Review of Smart Medical Devices in Worldwide Countries. This seminar will be held on September 25 at the National Taiwan University Hospital (NTUH) in Taipei, Taiwan. The latest medical device regulations and management measures in Taiwan, as well as the development of regulations for smart medical device in worldwide countries, will be outlined. Additionally, this seminar invites clinical and regulatory experts to share case studies and practical application expertise in the area of artificial intelligence (AI) and machine learning (ML) medical devices, in order to provide reference material for product development to related manufacturers and research teams.
On Wednesday, September 25 at 14:15 in Conference Room 402CD, International Conference Center, NTUH, COO of Amarex Taiwan, Dr. Chia-Hua Maggie Ho, will keynote on the topic of “AI/ML-based SaMD in med tech: how should it be applied and regulated?”
The number of US FDA approvals for AI/ML-based SaMD is expanding rapidly because the agency is actively developing a new regulatory framework to promote innovation in the AI/ML space. AI/ML-based SaMD can be used to support drug development, to aggregate data, synthesize information, seek patterns and optimize decisions. When used in drug development, it can help us understand the disease and targets, generate and evaluate drug candidates and combinations, improve trial design and advance precision medicine. This talk will present key principles of AI/ML-based SaMD as applied in drug development and as regulated by US FDA. Dr. Ho will present examples of AI/ML-based SaMD submissions to the FDA, and follow with a discussion of the challenges and future directions of AI/ML-based SaMD development.
To view the agenda or to register for this seminar, visit