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 within the organization.

3) Responsibilities

The Pharmacovigilance (PV) Manager is responsible for overseeing PASS activities. PV staff involved in PASS are responsible for adhering to this SOP.

4) Procedure

4.1 PASS Planning and Protocol Development

1. Identify the need for PASS based on regulatory requirements, risk management plans, or emerging safety concerns.
2. Develop PASS protocols outlining study objectives, methodology, data collection, analysis plan, and timelines.

4.2 PASS Implementation

1. Obtain regulatory approval or notification for PASS protocols from relevant authorities, as required.
2. Initiate PASS activities, including site selection, investigator training, data collection, and safety monitoring.

4.3 PASS Data Collection and Analysis

1. Collect safety data from participating sites according to the defined study protocol and data collection tools.
2. Analyze PASS data to evaluate the safety profile of the medicinal product and assess any identified risks.

4.4 PASS Reporting

1. Prepare PASS reports summarizing study findings, including safety outcomes, adverse events, and risk assessments.
2. Submit PASS reports to regulatory authorities within specified timelines and according to regional requirements.

4.5 PASS Follow-up

1. Respond