Speaker "Wenjing Wang" Details Back



Digital products' global regulations and the impact


Digital products including AI based apps, diagnostic software, etc. are playing more critical roles in remote patient care, decentralized clinical trials and drug development processes. The global regulations for the digital tools are evolving. This presentation will cover some regulatory knowledge on how digital products especially AI based apps are regulated as well as the impact to the IT industry.


Wenjing Wang is the Associate Director in Regulatory Affairs at Merck. She has over seven years of biomedical research experience and eight years of industry experience in Regulatory Affairs mainly focusing on device regulations. Her scientific background in Biochemistry, Molecular Biology, Regulatory Affairs and Biotechnology equipped her to effectively lead global registrations for Medical Devices, Digital Health Technologies, Combination Products and In Vitro Diagnostic Devices covering from FDA and Health Canada to the Notified Bodies, JMHW, NMPA, and other foreign regulatory bodies for submissions and strategy planning.