Sponsored by PointCross Life Sciences
The FDA has announced its intent to mandate nonclinical data submissions in standardized formats like SEND. Consequently, Agency reviewers expect to be spending more time on data analysis and detection of potential safety signals across studies. To guard against blind spots in your drug development lifecycle, wouldn’t you want to search, view and analyze your study data according to the new FDA standards? In this webinar, expects will discuss ways to improve the science of early safety signal detection, while assuring compliance with regulatory data submission requirements.
- Michael Brennan, Director of Informatics, Johnson & Johnson
- Gitte Frausing, Regulatory Professional, NovoNordisk
- Shree Nath, Vice President, PointCross Life Sciences
- Moderator: Ernie Bush, CSO, Drug Safety Executive Council
Webinar Highlights – Select links below to listen to panelist replies to the following questions:
- What tools does the FDA use to review SEND data and will they load it into Janus? (5:06)
- The industry has been discussing standardization for a while, but how is this going to affect my life as a toxicologist or study director on a day-to-day basis? Is this something that only concerns data management people? (7:16)
- What is the SEND standard and is it available from the FDA website? (0:59)
- What are the key considerations we should take into account to assess impacts on how we conduct studies today? (8:46)
- What about LIMS systems ability to support the SEND standard? How far back will they go? (2:46)
- Closing comments from the panelists. (2:59)
DSEC is a peer membership of over 2,000 drug safety leaders with the common objective of advancing the development of better and safer medicines. Membership is complimentary and limited to employees of pharmaceutical companies. DSEC also manages several industry consortia of biopharmaceutical companies that qualify preclinical safety platforms.