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Table Of Contents

Distribution Related Regulatory Authority
The Business Problem
PDMA Compliance Failures – The Impact
Is the FDA Serious About Monitoring Compliance?
PDMA Compliance Failures – The Experience
PDMA Impact on Pharmaceutical Sales
PDMA Impact on CRM
Sample Management Functional Requirements
Example PDMA Sample Compliance Program
Sample Accountability
Sample Management Technologies
Sample Tracking Vendors
Detailing and Ethical Issues
Promotion and Prescription Linkage
PhRMA – Code on Interactions With Healthcare Professionals
Compliance with the PhRMA Code
Off-Label Use: Regulatory Guidelines
Off-Label Use Regulatory Issues
Off-Label Use Violations: Retinol
Off-Label Use Violations: Topamax
Off-Label Use Violations: Thalidomide
Off-Label Use Violations: Propulsid
Off-Label Use Violations: Neurontin
Off-Label Use Dangers
Off-Label Use Penalties
Allowable Off-Label Use
Off-Label Use: Best Practices
The Able Laboratories Case
Misleading Promotional Materials
Vioxx Detailing Practices
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Published by: qmnweb on Mar 04, 2012
Copyright:Attribution Non-commercial


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