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Investigational Device Exemption Submissions Workshop

  • Date & Time
    October 9, 2019
  • Location
  • Event Type
  • Add to Calendar Disabled
Life Sciences Counsel Brian Malkin will speak at AdvaMed’s Investigational Device Exemption (IDE) Submissions Workshop in Washington, DC on October 9.

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.


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