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.
Recommended Actions
- Establish clear written policies for supporting educational activities
- Implement procedures to ensure separation between promotional and educational activities
- Create documentation templates for financial support agreements
- Develop a review process to ensure compliance with independence requirements
- Train relevant staff on the distinction between promotional and educational activities
- Maintain records of all supported educational activities and related agreements
- Regularly audit supported activities to ensure compliance with independence requirements
- Establish clear disclosure procedures for company support
- Create guidelines for appropriate interaction with educational providers
- 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
Related references and norms
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.