Safety Specification Section | PharmaBharat Tools

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Safety Specification Section | PharmaBharat Tools

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PV Risk ManagementSafety Specification Section

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Risk-Benefit Balance Pharmacovigilance Plan Section

Safety Specification Section

Risk Management

Definition

Section of RMP describing safety specification (known/unknown risks, missing information).

Example

Part III of EU RMP: safety specification.

Regulatory source

GVP Module V

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