Watch the replay of this webinar held on June 27
The FDA will soon require drug companies to transmit their nonclinical data submissions in standardized electronic formats like SEND. This will fundamentally impact workflows and data management within drug companies and CROs, and will require nonclinical toxicologists to become conversant with new ways of representing their data. FDA reviewers will use advanced computational safety signal detection and visualization tools to facilitate in-depth reviews of SEND submissions. Study directors will benefit by analyzing and reviewing their data internally in the same way that the FDA will be reviewing their submissions. The advent of this new era of “Computational Safety and Review Science” is expected to help identify and address potential toxicity findings sooner in the drug development lifecycle.
In this one hour interactive webinar, PointCross Life Sciences will explore the changes, challenges and opportunities facing biopharma companies as we debate the question “What does SEND Readiness really mean?” Join us for this exciting discussion – you won’t want to miss it!
PC-based attendees Required: Windows® 7, Vista, XP or 2003 Server
Macintosh®-based attendees Required: Mac OS® X 10.5 or newer