Post-Authorization Efficacy Study (PAES) | PharmaBharat Tools

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Post-Authorization Efficacy Study (PAES) | PharmaBharat Tools

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PV Real-World Data & RWEPost-Authorization Efficacy Study

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Post-Authorization Safety Study (PASS)Pregnancy Category

Post-Authorization Efficacy Study(PAES)

Real-World Data & RWE

Definition

Study to assess efficacy in real-world use when condition of approval; distinct from PASS but may include safety.

Example

Study to confirm efficacy in subpopulation per approval letter.

Regulatory source

EU Regulation 726/2004

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