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FEB
28

Regulatory Perspectives of Clinical Project Management: Meeting FDA Requirements for Clinical Trials

Conference
When the 28/02/12
Where Online Event
Description
This 90-minute webinar will provide an overview of regulatory management for clinical trials. It will discuss key regulatory aspects of a clinical project such as clinical protocol management, IRB management, safety reporting, rules for recruitment programs, seeking advice from FDA, trial master files, and training requirements.
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Price $299.00

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Agenda for Regulatory Perspectives of Clinical Project Management: Meeting FDA Requirements for Clinical Trials

Areas Covered in the Seminar:

  • Overview of FDA requirements for clinical trials under an IND or IDE application.
  • Regulatory responsibilities of the clinical project manager.
  • An ideal clinical trial protocol and processes to amend it.
  • Addressing adverse events and safety reporting.
  • Management of randomization, blinding, unblinding, and DSMB review.
  • Managing investigational products: stability, storage, accountability, and expiry.

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