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
- Identify the need for PASS based on regulatory requirements, risk management plans, or emerging safety concerns.
- Develop PASS protocols outlining study objectives, methodology, data collection, analysis plan, and timelines.
4.2 PASS Implementation
- Obtain regulatory approval or notification for PASS protocols from relevant authorities, as required.
- Initiate PASS activities, including site selection, investigator training, data collection, and safety monitoring.
4.3 PASS Data Collection and Analysis
- Collect safety data from participating sites according to the defined study protocol and data collection tools.
- Analyze PASS data to evaluate the safety profile of the medicinal product and assess any identified risks.
4.4 PASS Reporting
- Prepare PASS reports summarizing study findings, including safety outcomes, adverse events, and risk assessments.
- Submit PASS reports to regulatory authorities within specified timelines and according to regional requirements.
4.5 PASS Follow-up
- Respond to regulatory inquiries or requests for additional information regarding submitted PASS reports.
- Monitor and update PASS protocols and reports as necessary based on emerging safety data or regulatory feedback.
4.6 Documentation and Record Keeping
- Maintain comprehensive records of PASS planning, protocol development, implementation, and reporting.
- Ensure that all PASS documentation is stored securely and is accessible for regulatory inspections and audits.
4.7 Training and Education
- Provide training to PV staff and study personnel on PASS protocols, data collection procedures, and regulatory requirements.
- Ensure that study investigators and site staff are informed about their roles and responsibilities in PASS execution.
4.8 Continuous Improvement
- Regularly review PASS procedures and protocols based on study outcomes, regulatory changes, and inspection findings.
- Implement improvements to enhance study efficiency, data quality, and compliance with evolving regulatory requirements.
5) Abbreviations, if any
PV – Pharmacovigilance, SOP – Standard Operating Procedure, PASS – Post-Authorization Safety Study
6) Documents, if any
PASS protocols, study reports, regulatory notifications, training materials.
7) Reference, if any
ICH Guideline for Good Clinical Practice, FDA Guidance for Industry – Postmarketing Studies and Clinical Trials, EU Guidelines on Good Pharmacovigilance Practices (GVP) Module VIII – PASS.
8) SOP Version
Version 1.0
