Pharmaceutical Postmarket Surveillance
Latest Developments in the Era of COVID-19

Are you compliant with the postmarket surveillance guidance the FDA released during the pandemic? And the current FDA postmarket adverse event reporting regulations?

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.

Cynthia Schnedar, Executive Vice President of Regulatory Compliance at Greenleaf Health and former Director of the Office of Compliance for FDA’s Center for Drug Evaluation and Research (CDER) and Dawn Wynder, a Project Manager for FDAQRC and former FDA Investigator, will ensure you understand how the agency conducts its postmarket safety surveillance and what you must do to ensure postmarket adverse reporting inspection readiness.

Webinar Takeaways:

• 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


• What data elements are required for valid adverse event submissions


• How the FDA will evaluate adverse event reporting during a postmarket inspection

Make sure your postmarket safety surveillance is compliant during the pandemic and beyond by attending this webinar. Join us by registering today.

Who Will Benefit

• Auditors
• QA/QC personnel
• R&D management
• Compliance officers
• Executive management
• Laboratory management
• Risk management specialists
• Regulatory/legislative professionals
• Manufacturing directors and supervisors
• Validation specialists, scientists