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Latest Developments in the Era of COVID-19 Webinar March 18, 2021

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WCG FDAnews

WCG FDAnews


FALLS CHURCH, Va. (PRWEB)

Pharmaceutical Postmarket Surveillance:

Latest Developments in the Era of COVID-19

An FDAnews Webinar

Thursday, March 18, 2021, 1:30 p.m.-3:00 p.m. EDT

https://www.fdanews.com/pharmapostmarketsurveil

Are you confident you’re compliant with current FDA postmarket adverse event reporting regulations? Postmarket surveillance can be difficult during the best of times. And in the COVID-19 era it’s become even more difficult.

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 a former FDA Investigator, will ensure attendees understand how the FDA conducts its postmarket safety surveillance and what one must do to ensure postmarket adverse reporting inspection readiness.

Using the FDA guidance released during the pandemic, they’ll explain:


  • What the FDA Adverse Event Reporting System (FAERS) is, how the FDA evaluates the information in the FAERS database and what regulatory action that the 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 one’s postmarket safety surveillance is compliant during the pandemic and beyond by attending this webinar.

Interested in registering multiple sites?

Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally to learn about our special multisite discount.

Webinar Details:

Pharmaceutical Postmarket Surveillance:

Latest Developments in the Era of COVID-19

An FDAnews Webinar

Thursday, March 18, 2021, 1:30 p.m.-3:00 p.m. EDT

https://www.fdanews.com/pharmapostmarketsurveil

Tuition:

$287 per site

Easy Ways to Register:

Online: https://www.fdanews.com/pharmapostmarketsurveil

By phone: 888.838.5578 or 703.538.7600

About FDAnews:

FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews’ print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA’s complex and ever-changing regulations

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