GUEST CONTRIBUTORS

  • What Value-Based Reimbursement Means For Drug Development
    What Value-Based Reimbursement Means For Drug Development

    Pharmaceutical reimbursement historically has largely been a process of first determining the efficacy and safety profile of a therapy and then deciding its ultimate coverage level based on its price. But now, payers are taking a cue from their European peers and beginning to do the sophisticated number-crunching and cost-effectiveness studies to take a more holistic approach to drug coverage.

  • 3 Steps To Capitalize On Real-World Data Under 21st Century Cures
    3 Steps To Capitalize On Real-World Data Under 21st Century Cures

    Randomized clinical trials (RCTs) of prescription drugs and other medical products have been considered the gold standard of evidence to support decision making by clinicians and policymakers. However, it is increasingly recognized that most RCTs are unable to generate information about a product’s real-world effectiveness. Measures such as long-term outcomes, comparisons among multiple treatment options, and utilization are not well captured in trials. Furthermore, benefit-risk balance and value for money are best learned in cost-effectiveness or cost-benefit analyses.

  • Does The First-Patient-In Milestone Really Matter?
    Does The First-Patient-In Milestone Really Matter?

    Sorry, pharma executives. We have all been duped for years that the FPI milestone yields an increase in stock price and company value.

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Implementing the ASTM E2500 Validation Method: 10 Years of Key Learnings November 28, 2017
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Implementing the ASTM E2500 Validation Method: 10 Years of Key Learnings November 28, 2017
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The Top Method Validation Mistakes – And How to Avoid Them November 29, 2017
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An Introduction to Good Laboratory Practices (GLP) December 5, 2017
1pm-2:30pm EDT, Online Training
Auditing Validated Computer Systems In A GxP Environment December 12, 2017
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