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OPDP/APLB and Compliance 101: A Primer
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TUTORIAL
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Tuesday, Feb 19
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1:30PM - 5:00PM
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ACPE, IACET
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Welcome and Opening Remarks
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SESSION
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Wednesday, Feb 20
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8:25AM - 8:30AM
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FDA Update: Recent Enforcement Actions
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SESSION
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Wednesday, Feb 20
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8:30AM - 10:00AM
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ACPE, IACET
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Substantial Evidence and Other Standards of Evidence in Promotion
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SESSION
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Wednesday, Feb 20
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10:30AM - 12:00PM
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ACPE, IACET
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FDA Guidance Update
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SESSION
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Wednesday, Feb 20
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1:30PM - 2:30PM
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ACPE, IACET
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Social Media: Digital Tools and Considerations in Compliant Development
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SESSION
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Wednesday, Feb 20
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2:30PM - 3:30PM
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ACPE, IACET
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Recent Updates and Future Trends in Corporate Integrity Agreements and Compliance Programs
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SESSION
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Wednesday, Feb 20
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4:00PM - 5:00PM
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ACPE, IACET
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Disease State and Unbranded Materials - Regulatory Challenges
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SESSION
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Thursday, Feb 21
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8:30AM - 10:00AM
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ACPE, IACET
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Fundamental Issues in the Regulatory Evaluation of Health Economic Information
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SESSION
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Thursday, Feb 21
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8:30AM - 10:00AM
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ACPE, IACET
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Product Communications in the Pre-Approval Phase
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SESSION
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Thursday, Feb 21
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8:30AM - 10:00AM
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ACPE, IACET
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Disease State and Unbranded Materials - Regulatory Challenges
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SESSION
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Thursday, Feb 21
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10:30AM - 12:00PM
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ACPE, IACET
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Fundamental Issues in the Regulatory Evaluation of Health Economic Information
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SESSION
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Thursday, Feb 21
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10:30AM - 12:00PM
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ACPE, IACET
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Product Communications in the Pre-Approval Phase
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SESSION
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Thursday, Feb 21
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10:30AM - 12:00PM
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ACPE, IACET
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The Next Generation: Promotional Review Boards (Online reviews)
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SESSION
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Thursday, Feb 21
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1:30PM - 2:30PM
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ACPE, IACET
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Question and Answer Session with FDA
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SESSION
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Thursday, Feb 21
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3:00PM - 4:00PM
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ACPE, IACET
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Closing Remarks
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SESSION
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Thursday, Feb 21
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4:00PM - 4:15PM
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ACPE, IACET
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