SOP for Pharmacovigilance Post-Authorization Safety Studies (PASS)
SOP for Pharmacovigilance Post-Authorization Safety Studies (PASS) Guidelines for Pharmacovigilance Post-Authorization Safety Studies (PASS) 1) Purpose The purpose of this SOP is to establish procedures for the planning, conduct, and reporting of Post-Authorization Safety Studies (PASS) in pharmacovigilance. 2) Scope This SOP applies to pharmacovigilance personnel responsible for the design, execution, and oversight of PASS…
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