Course 4: Premarket Annual Safety Reports
Coming Soon
Courses 4 and 5 address premarketing safety surveillance and postmarketing pharmacovigilance collection, evaluation, and reporting of individual safety case reports (or ICSRs) that identify detailed information regarding the circumstances, and possible contributory factors leading to an adverse event(s)in a patient. However, it is often only after review of several adverse event reports of a similar nature, in aggregate, that a potential drug safety signal is typically detected.
Periodic safety reporting is required by regulation of all Sponsors of clinical studies and MAH/license holders of drug and biologic products throughout the product lifecycle. Courses 4 and 5 provide you with an understanding of the requirements for periodic safety reports required by US and EU regulations during the premarketing and postmarketing phases. Course 4 addresses the content and timeline requirements for Investigational New Drug (IND) Annual Reports in the US and Annual Safety Reports in the EU, as well as the recommended, harmonized Development Safety Update Report (DSUR) during clinical development. Course 5 addresses the content and timeline requirements for US Periodic Adverse Drug Experience Reports (PADERs) and Periodic Safety Update Reports (PSURs).
