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CBER BEST Initiative Seminar Series - COVID-19 pharmacoepidemiology in Canada
Topic: COVID-19 pharmacoepidemiology in Canada

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.

Description: The Canadian Network for Observational Drug Effect Studies (CNODES) is mandated by Health Canada to conduct studies on drug utilization, safety, and effectiveness CNODES is currently engaged in several Health Canada-assigned studies of potential treatments for COVID-19 and of COVID-related side-effects of commonly used medications, including some requested by international regulators. Finally, CNODES is providing methodological support to proposed studies of COVID-19 vaccine safety and effectiveness in Canada. I will review this work, and some of the challenges specific to observational studies of drug and vaccine safety in the Canadian setting.

Presenter: Robert Platt, PhD
Robert Platt is Professor in the departments of Pediatrics and of Epidemiology, Biostatistics, and Occupational Health (EBOH) at McGill University. He is a Senior Investigator at the Research Institute of the McGill University.

Sep 8, 2021 11:00 AM in Eastern Time (US and Canada)

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