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Overview
Learning objectives
- Apply epidemiologic methods to drug/biologic/device safety surveillance
- Recognize the role of epidemiology during product development
- Explain the advantages and limitations of various study designs, and make recommendations about the best approaches to address safety analyses
- Determine how to identify the best data source(s) for answering a regulatory requirement for post-marketing surveillance
- Describe sources of “big data” and their value in safety surveillance and risk management
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Pharmacovigilance and Risk Management Strategies.