Start Date: 4/4/2023 10:00 AM PDT
End Date: 4/4/2023 12:00 PM PDT
Venue Name: VIRTUAL
Organization Name:
AHPA
Contact:
Manufacturers of dietary supplements play a key role in consumer safety. If an adverse event associated with a dietary supplement occurs, the manufacturer is responsible for documenting and thoroughly investigating the issue. As for serious adverse events reports (SAERs), manufacturers are obligated to document and submit any such reports that meet the law’s definition of “serious” to the U.S. Food & Drug Administration (FDA) in a timely matter. Failure to submit SAERs to FDA has consequences.
Join us for this webinar on April 4, 2023 to learn more about post-market surveillance and adverse event reporting, including:
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An overview of the industries’ obligations per the regulation
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What defines an adverse event and a serious adverse event
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Requirements for submitting serious adverse event reports
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Issues that can occur when reporting and how to avoid them
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A focus on what FDA does once a report is received
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How to scale your business and stay align with regulatory requirements
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Serious adverse event reporting data and observations
Questions:
There will be a Q&A session at the end of the webinar for speakers to answer specific questions from attendees. Attendees may submit questions in advance by email to Melissa Do at mdo@ahpa.org or during the webinar.
Presenters:
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Kristy Appelhans, VP, Global Consumer Safety, Herbalife Nutrition
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Rick Kingston, President, SafetyCall International
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Oliver Ou, CFSAN Adverse Event Reporting System (CAERS) Coordinator, U.S. Food & Drug Administration
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Michael McGuffin, President, AHPA
Registration:
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AHPA Members: $199
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Non-Members: $399