If the pandemic is making your postmarket surveillance even more difficult, you’re not alone.
During this webinar, two former FDAers explain how to comply during the pandemic and beyond.
Our speaker, will ensure you understand how the agency conducts its postmarket safety surveillance and what you must do to ensure postmarket adverse reporting inspection readiness.
What the FDA Adverse Event Reporting System (FAERS) is, how the FDA evaluates the information in the FAERS database and what regulatory action that FDA may take if it detects a safety signal from its data review
Nuances of the FDA Program Guide CHAPTER 53 — Postmarketing Surveillance and Epidemiology: Human Drug and Therapeutic Biological Products Program: 7353.001, including how this program guide is a critical tool that sponsors should be using to ensure they are in compliance and prepared for an FDA inspection on postmarket adverse event reporting
How the FDA uses its MedWatch program to provide information on mandatory reporting by manufacturers
What type of reports a manufacturer must submit to the FDA when deviation from current good manufacturing practice regulations occur.