FDAnews Drug Safety Reporting Requirements: Best Practices for Monitoring, Reporting and Avoiding Regulatory Missteps Webinar December 9, 2021

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Successful drug safety reporting compliance: Former FDA Associate Chief Counsel/Enforcement explains what one must know and do to comply.

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Drug Safety Reporting Requirements:
Best Practices for Monitoring, Reporting and Avoiding Regulatory Missteps
An FDAnews Webinar
Thursday, Dec. 9, 2021, 1:30 p.m.-3:00 p.m. EST
https://wcg.swoogo.com/drug-safety-reporting-requirements

Pharmacovigilance issues? Poor drug safety monitoring or inadequate adverse event reporting can have devastating consequences for patients.

The FDA’s evaluation of safety risks and adverse events can lead to a drug’s removal from the market. Failure to comply with pharmacovigilance requirements can mean regulatory action; it can also mean civil or criminal enforcement by the Department of Justice.

Beth Packman Weinman — counsel in Ropes & Gray’s life sciences regulatory and compliance practice group and former associate chief counsel for enforcement within FDA’s Office of Chief Counsel — will explain what one must know and do to ensure compliance.

Using real-world examples, she will provide attendees with a sophisticated understanding of pharmacovigilance, best practices for monitoring sources of complaints, how to comply with reporting requirements and the consequences of failing to comply, sharing:

  • Why pharmacovigilance matters — includes recent real-world safety alerts and drug safety reporting that led to the removal of warnings
  • How to comply with premarket and postmarket adverse event reporting requirements — includes what information must be reported, to whom, how, on what forms and within what required time frames
  • How the FDA uses reports to detect safety signals and how it makes drug safety information available to the public
  • When and why there is a phase 4 (postapproval) study requirement for drugs subject to accelerated approval
  • What a company’s obligations are for monitoring sources of safety information and tracking complaints, including with respect to social media
  • When reported adverse events might lead to an FDA Safety Communication — or a request for a recall
  • What the regulatory and judicial enforcement consequences are of failing to comply with drug safety reporting requirements — includes recent real-world warning and untitled letters citing reporting failures and DOJ settlements focusing on such allegations

Pharmacovigilance is too important to get wrong. This webinar will ensure one will get it right.

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:
Drug Safety Reporting Requirements:
Best Practices for Monitoring, Reporting and Avoiding Regulatory Missteps
An FDAnews Webinar
Thursday, Dec. 9, 2021, 1:30 p.m.-3:00 p.m. EST
https://wcg.swoogo.com/drug-safety-reporting-requirements

Tuition:
$297 per site

Easy Ways to Register:
Online: https://wcg.swoogo.com/drug-safety-reporting-requirements
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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Dominque Hudson
FDAnews
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