Module 6

03/10/2024

In this presentation we will cover

Demonstrating value of medicines

HTA processes

HTA and Regulatory Authorities

Regulatory Affairs role

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Regulatory and HTA Overlaps

Scientific Advice Early Regulatory Advice at EU Level to meet Regulatory Questions Emerging HTA Advice at National Level to answer HTA Questions ? Is EU level advice possible for HTA ? How does “Joint” or “Parallel” Advice work today Comparisons to Other Drugs Regulatory Package includes some comparators for Relative Efficacy HTA desire Relative Effectiveness ? Do Regulators need more comparative efficacy ? How to improve value of EPAR Phase IV Research Commitments Regulatory Risk Management Plan HTA Real World Relative Effectiveness follow ups ? Should Regulators, HTA bodies, or Industry define the most appropriate comparative effectiveness evidence

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