Navigating the Regulatory Steps in Biotherapeutic Translation Workshop
About the workshop:
The Navigating the Regulatory Steps in Biotherapeutic Translation workshop, jointly hosted by BioCanRx, OIRM and SCN, is designed to provide scientists with an overview of the regulatory landscape and clarify the processes and steps required to translate discoveries into clinical trials. The workshop will provide participating teams with an overview of the steps necessary for developing pre- and full Clinical Trials Application (CTA) submissions to Health Canada, in addition to outlining the process of engaging with Health Canada as pre- and full CTAs are evaluated. In this interactive workshop, teams will also gain exposure to the regulatory considerations surrounding manufacturing and clinical testing, as well as discuss the workshop content and their own use scenarios with subject matter experts in the clinical trials, regulatory processes and cell and virus manufacturing fields.
The goal is to provide investigators with an understanding of the key stages and steps that will be required during the translation of their discoveries into novel biotherapeutic agents, particularly using cells, gene-modified cells, and/or viruses, for cancer and regenerative medicine applications in an academic setting.
For more information about the workshop and how to apply (spaces are limited), please visit the below webpage:
The deadline to apply is 11:59 p.m. (sender’s time), November 25, 2019.