Pei Ting Sarah Chou

Title: Regulatory framework of in vitro diagnostic and artificial intelligence for precision medicine

Abstract:

First, the existing regulatory frameworks for in vitro diagnostic and artificial intelligence medicinal products will be examined. Among those medicinal products of in vitro diagnostic and artificial intelligence, the ones characterized as precision medicine, or personalized medicine, will be evaluated from the aspects of the policy of health authorities and the needs of users. Second, the challenges encountered during the COVID-19 pandemic for developing and utilizing the medicinal products of in vitro diagnostic and artificial intelligence for precision medicine within the current regulatory framework will be pointed out and discussed. Third, recent breakthroughs of precision medicinal technology within the domains of in vitro diagnostic and artificial intelligence will be reviewed so that the evolving roles of regulatory agencies will be discussed. Next, concerns about the tolerance of the risk and the needs of the patients for these recent breakthroughs of precision medicinal technology within the domains of in vitro diagnostic and artificial intelligence will be raised and assessed, especially for the medicinal products of in vitro diagnostic and artificial intelligence with early interventions for life-threatening diseases. Corresponding to this part, the existing regulatory frameworks for in vitro diagnostic and artificial intelligence medicinal products will be reviewed and assessed accordingly. Last, several perspectives of precision medicinal products in terms of opportunities and challenges will be identified, which includes aspects of the good practice of precision medicine, the ethical consideration, the future advancement of regulatory framework, and the breakthrough of precision medicine technology within the realm in vitro diagnostic and artificial intelligence after the COVID-19 pandemic.

Biography:

Sarah is a U.S./Taiwan certified regulatory professional and ISO13485/ISO9001 lead auditor with European regulatory trainings funded by DAAD and British Council. She is the founding Board of Director at Regulatory Affairs Professional Society (RAPS) Taiwan and Quantic Law Society. As the author of International Regulatory Affairs books published by RAPS, she has led the teams at North American, European & Taiwanese firms as regulatory head to pass audits conducted by health authorities from around the globe. Having delivered some health authority training programs, she is also a reviewer of International Production Journal and a medical writer of scientific communication agency.