Enforcement: An Update

Explores recent FDA enforcement of FDAAA 801 and noncompliance pitfalls to avoid.

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About this Webinar

Recently, there have been updates to enforcement and various initiatives to drive transparency. Institutions are challenged to build robust compliance programs and individuals must be empowered to understand the regulations and learn helpful tips to lead their organizations.

This webinar reviews U.S. Food and Drug Administration (FDA) notices of noncompliance. The presenter discusses modernization of the Protocol Registration and Results System (PRS) which is used to register protocols and submit results to the database. He also draws on his experience to identify common pitfalls to avoid noncompliance.

Webinar Demo:

Release Date: February 3, 2022

Language Availability: English

Suggested Audiences: Clinical Research Coordinators (CRCs), Clinical Researchers, Institutional Officials, Investigators, Sponsors

Organizational Subscription Price: $300 per year/per site or included as part of an annual subscription to our All Access Webinar Package
Independent Learner Price: $49 per person

Webinar Content Enforcement: An Update

Presented by: Anthony Keyes, MBA, PMP - Johns Hopkins University

Learning Objectives:

  • Review recent FDA notices of noncompliance.
  • Identify and mitigate potential noncompliance pitfalls.
  • Discuss modernization of the Protocol Registration and Results System (PRS) and database by the National Library of Medicine (NLM).

Recommended Use: Required
ID (Language): 20560 (English)

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