Continuing Education Credits are not available for the on demand offering.
Broadcast time: 1 hour 22 minutes 
 

To take full advantage of the opportunities afforded by advances in pharmacoepidemiology and to integrate this with pharmacological mechanism-based approaches, FDA is leveraging the new capabilities of the Sentinel System and in parallel making use of bioinformatic, cheminformatic and systems pharmacology approaches for the evaluation of potential post-approval safety signals and for the prediction of safety signals earlier in drug development.  The Sentinel System is providing a powerful complementary approach to the long standing spontaneous adverse drug event reporting system.  The cheminformatic and bioinformatic approaches target adverse event profiles and predict off-target drug binding.  The systems pharmacology approaches seek to better understand and predict mechanisms of adverse drug effects across multiple levels of biological organization.  The goal of these innovative methods is to better predict adverse events, drug toxicity and to help bridge the gap between non-clinical and clinical drug safety.

In this webinar, FDA speakers from the Office of Clinical Pharmacology will discuss the development and implementation of some of these predictive tools and methods that are being used to complement ongoing efforts in drug safety within the agency.  The pharmacoepidemiological, bioinformatics, and systems pharmacology approaches all require input and collaboration from multiple stakeholders in order to move these programs forward and help improve the science of pharmacovigilance and safety of medicines.