Hosted Webinar: DSEC Panel Discussion: Search, Analytics and SEND: Guarding Your Drug Safety Blind Spots

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.

Panelists Include:

  • 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:

About DSEC
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.