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Maintaining Independence of Industry-Supported Scientific and Educational Activities

This guidance addresses the distinction between independent scientific/educational activities supported by medical product companies and promotional activities. It provides direction on how companies can support educational activities while maintaining their independence from promotional influence.

  1. Establish clear written policies for supporting educational activities
  2. Implement procedures to ensure separation between promotional and educational activities
  3. Create documentation templates for financial support agreements
  4. Develop a review process to ensure compliance with independence requirements
  5. Train relevant staff on the distinction between promotional and educational activities
  6. Maintain records of all supported educational activities and related agreements
  7. Regularly audit supported activities to ensure compliance with independence requirements
  8. Establish clear disclosure procedures for company support
  9. Create guidelines for appropriate interaction with educational providers
  10. Implement monitoring system for potential conflicts of interest

Key Considerations

Other considerations

  • Provider must maintain full control over the content, faculty, educational methods, and materials
  • Company’s role must be limited to providing financial support
  • No direct influence on program content or speaker selection
  • Clear disclosure of company support must be made
  • Physical separation between promotional exhibits and educational activities
  • No requirement for attendees to visit promotional exhibits
  • Educational provider must be independent from the supporting company
  • Supporting company cannot suggest content or speakers
  • Materials distributed should be free from commercial bias

    Relevant Guidances

  • Industry-Supported Scientific and Educational Activities: Maintaining Independence from Promotional Influence

No specific norms or standards referenced in this guidance.


Original guidance

  • Maintaining Independence of Industry-Supported Scientific and Educational Activities
  • HTML / PDF
  • Issue date: 1997-11-01
  • Last changed date: 2020-04-24
  • Status: FINAL
  • Official FDA topics: Medical Devices, Drugs, Animal & Veterinary, Biologics, Administrative / Procedural
  • ReguVirta summary file ID: 0034a8dd9ff24ed280e044eefed4d5cc
This post is licensed under CC BY 4.0 by the author.