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CBER BEST Seminar Series - Evaluating Use of Methods for Adverse Event Under Surveillance For Vaccines
Background: The CBER BEST Initiative Seminar Series is designed to share and discuss recent research of relevance to ongoing and future surveillance activities of CBER regulated products, namely biologics. The series focuses on safety and effectiveness of biologics including vaccines, blood components, blood-derived products, tissues and advanced therapies. The seminars will provide information on characteristics of biologics, required infrastructure, study designs, and analytic methods utilized for pharmacovigilance and pharmacoepidemiologic studies of biologics. They will also cover information regarding potential data sources, informatics challenges and requirements, utilization of real-world data and evidence, and risk-benefit analysis for biologic products. The length of each session may vary, and the presenters will be invited from outside FDA. Please see the details below for our upcoming seminar. Anyone can register and join for free. Stay tuned for more details and additional webinars during the year.

Topic: Evaluating Use of Methods for Adverse Event Under Surveillance (for vaccines) (EUMEAUS)

Speaker: Dr. Nicole Pratt
Professor, University of South Australia

Description: As recently approved COVID-19 vaccines are rolled out globally, safety signals will be identified from spontaneous reports and other data sources. Although some work has been done to assess the validity of methods for vaccine safety surveillance, discussion remains on the best way to perform analyses in real-world data to ensure rigorous and rapid identification of safety signals. In this talk, we will discuss the “Evaluating Use of Methods for Adverse Event Under Surveillance (for vaccines) (EUMEAUS)” task force and its findings on the comparative performance of different analytical methods for the assessment of comparative vaccine safety. We will discuss our findings to-date describing our evaluation of different surveillance methods (historic rate, cohort, self-controlled, etc).

Feb 23, 2022 11:00 AM in Eastern Time (US and Canada)

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