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CBER BEST Initiative Seminar Series - Vaccine safety evaluation using the self-controlled case series method
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: Vaccine safety evaluation using the self-controlled case series method

Speaker: Dr. Heather Whitaker
Senior Statistician @UK Health Security Agency (formerly Public Health England)

Description: The self-controlled case series (SCCS) method will be introduced in the context of vaccine safety evaluation, with examples. We will also consider some of the methodological extensions of the SCCS method that have been used in vaccine safety studies, particularly those relevant to studies of COVID-19 vaccine safety.

Dec 1, 2021 11:00 AM in Eastern Time (US and Canada)

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