Workshop 3: Regulatory Challenges for Medical Products
Timeslot: Wednesday, April 19, 2023 - 9:00am to 12:00pm
Room: Coral 1-2
About
One major hurdle toward translating medical products is meeting the regulatory requirements. In this session we will discuss all aspects of the regulatory challenges with a focus on US FDA requirements such as regulatory pathway, pre-clinical bench testing, animal study, biocompatibility, clinical trial, etc. The session will also introduce the regulatory science approaches to facilitate the translation of medical products.