This is the one conference that should be attended by your entire promotional review team. This two-day program will give attendees the opportunity to interact with speakers, regulatory agency personnel and other industry participants in a dynamic and informative environment. Sessions will feature presentations, panel discussions, and Q&A.
Half Day Tutorial:
Session Topics:
- FDA Update: Recent Enforcement Actions
- Substantial Evidence and Other Standards of Evidence in Promotion
- FDA Guidance Update
- Social Media: Digital Tools and Considerations in Compliant Development
- Recent Updates and Future Trends in Corporate Integrity Agreements and Compliance Programs
- Product Communications in the Pre-Approval Phase
- Fundamental Issues in the Regulatory Evaluation of Health Economic Information
- Disease State and Unbranded Materials – Regulatory Challenges
- The Next Generation: Promotional Review Boards (online reviews)
- Question and Answer Session with FDA
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