Considerations for REMS Surveys and Assessments: Planning and Reporting - Pharmacovigilance 2020
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Күн бұрынDoris Auth and Shelly Harris from CDER’s Division of Risk Management (DRM) describe the requirements for REMS assessments, the importance of REMS assessment planning during REMS development. They share considerations when developing REMS knowledge survey methodologies and describe best practices for conducting REMS assessments and surveys.
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