Investigational Device Exemption Submissions Workshop
Date & Time
October 9, 2019
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The interactive workshop will explore regulatory guidelines governing IDEs, including the purpose of an IDE, components of a successful IDE submission, common errors and deficiencies in an IDE application, and more. In a session titled “Regulatory Compliance During Study Conduct,” Brian will cover monitoring, consenting of patients, enrollment requirements, adverse event reporting, sponsor and investigator records and reports, and protocol deviations.