When it comes time to file a Clinical Trial Application for new cell or gene therapy products, a New Substance Notification Regulation (Organism) Schedule 1 form may also need to be filed with Environment and Climate Control Canada (ECCC). This is often true for products touched by biotech, including vector-modified or gene edited cells, such as CAR-T. But what necessitates the submission of this extra form? Why does it need to go to ECCC, where other forms are sent to Health Canada? And what’s being done to make the CTA process smoother for innovators? Tune in to hear Dr. Sowmya Viswanathan explain her work on clarifying the NSNR(O) process.
Join us at 12PM.
Register here.