Pharmaceutical Postmarket Surveillance: Latest Developments in the Era of COVID-19 – Webinar Recording/Transcript
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 presentation, 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.
- 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 presentation.
Meet Your Presenters
Cynthia Schnedar, Executive Vice President of Regulatory Compliance at Greenleaf Health, provides strategic advice to clients in the life sciences industry. She was formerly Director of the Office of Compliance for FDA’s Center for Drug Evaluation and Research (CDER), where she spearheaded efforts to protect the American public from unsafe and ineffective drug products by ensuring that companies comply with federal standards for quality and safety. Before joining FDA, Ms. Schnedar served in leadership positions at the Department of Justice, where she specialized in compliance and enforcement issues.
Dawn Wynder is a Project Manager for FDAQRC. She has extensive FDA regulatory compliance and industry quality and compliance expertise. She has been a sought-out subject matter expert with a proven track record of consistently establishing proactive compliance and application of quality oversight. Ms. Wynder offers a firm grasp of all aspects of operational strategy, coordination and conduct of all pharmaceutical research and development, medical device and consumer markets; audit and compliance, safety and quality monitoring; and operational risk management across all GxPs. She brings over 10 years’ experience as an FDA Investigator, where she led and conducted BIMO GCP and GLP inspections, postmarket adverse event reporting inspections, drug and device GMP inspections assessing compliance with FDA regulations, biologics inspections enforcing the GxPs and many more.
Who Will Benefit
- 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
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March 18, 2021