February 21, 2019 @ 11:00 am
Approximately one-third of all medical products developed today are combination products. These devices require a unique approach when applying for regulatory approval. In this hour-long webinar, Michael Dellogono, Ph.D., will discuss how to select the correct testing pathway and what regulatory requirements your device must meet – helping you reduce the time and stress involved […]
April 25, 2019 @ 11:00 am
Jumpstarting Your Biological & Biosimilar Development: Bringing Cell & Gene Therapies to Agency Submission
Preclinical safety testing is an integral part of ensuring the successful development of biosimilars & biologics, but how do you navigate this process for these similar but unique products? What special endpoints do you need to consider when developing innovative cell and gene therapies? While biologics follow a process similar to the pharmaceutical IND process, there are key differences.
May 30, 2019 @ 11:00 am
A complete biocompatibility evaluation profile is an essential step in gaining regulatory approval of your new medical device. What happens when you find out that the device your company is riding on fails a biocompatibility endpoint evaluation? How could this happen? What are you to do next?