Guidelines for Pharmacovigilance ICH Guidelines Compliance

1) Purpose

The purpose of this SOP is to ensure compliance with International Conference on Harmonization (ICH) guidelines related to pharmacovigilance activities, including safety reporting, risk management, and regulatory submissions.

2) Scope

This SOP applies to personnel involved in pharmacovigilance operations, including pharmacovigilance officers, safety scientists, medical reviewers, and regulatory affairs professionals.

3) Responsibilities

The Pharmacovigilance Compliance Officer is responsible for overseeing compliance with ICH guidelines. Pharmacovigilance officers and safety scientists ensure adherence to guidelines in safety reporting, risk management, and regulatory submissions.

4) Procedure

4.1 ICH Guidelines Familiarization

1. Review and familiarize with relevant ICH guidelines applicable to pharmacovigilance activities, including but not limited to ICH E2E, E2D, E2F, E6, and E9.
2. Understand the requirements and recommendations outlined in each guideline related to safety surveillance, risk management, clinical safety data management, and pharmacovigilance systems.

4.2 Implementation of ICH Guidelines

1. Integrate ICH guidelines into pharmacovigilance processes, procedures, and workflows to ensure standardized practices across safety surveillance activities.
2. Implement specific requirements for safety reporting timelines, expedited reporting, periodic safety update reports (PSURs), and signal detection and management as per ICH guidelines.

4.3 Documentation and Record Keeping

1. Maintain comprehensive documentation of ICH guideline implementation, including policy documents, standard operating procedures (SOPs), and procedural guidelines.
2. Document deviations from ICH guidelines, corrective actions taken, and any updates to procedures or practices to ensure continuous compliance.

4.4 Compliance Monitoring and Auditing

1. Conduct regular audits and compliance assessments to monitor adherence to ICH guidelines in pharmacovigilance activities.
2. Collaborate with internal audit teams, quality assurance units, and regulatory affairs to address findings from audits and implement corrective actions.

4.5 Training and Development

1. Provide training sessions and workshops on ICH guidelines to pharmacovigilance staff, including updates on guideline revisions, new requirements, and best practices.
2. Ensure ongoing competency and awareness among pharmacovigilance professionals regarding ICH guidelines through continuous education and training initiatives.

4.6 Continuous Improvement

1. Monitor updates and revisions to ICH guidelines and regulatory requirements affecting pharmacovigilance operations.
2. Implement improvements in pharmacovigilance practices, procedures, and systems to align with evolving ICH guidelines and industry standards.

5) Abbreviations, if any

PV – Pharmacovigilance, SOP – Standard Operating Procedure, ICH – International Conference on Harmonization, PSUR – Periodic Safety Update Report

6) Documents, if any

ICH guideline documents, SOPs for ICH compliance, audit reports, training materials.

7) Reference, if any

ICH E2E – Pharmacovigilance Planning, ICH E2D – Post-Approval Safety Data Management, ICH E2F – Development Safety Update Report, ICH E6 – Good Clinical Practice, ICH E9 – Statistical Principles for Clinical Trials.

8) SOP Version

Version 1.0