Guidelines for Conducting Pharmacovigilance Compliance Training

1) Purpose

The purpose of this SOP is to outline the procedures for conducting pharmacovigilance compliance training to ensure that all personnel involved in pharmacovigilance activities are adequately trained and compliant with regulatory requirements and company policies.

2) Scope

This SOP applies to all employees and contractors involved in pharmacovigilance activities, including new hires and current staff requiring refresher training.

3) Responsibilities

The Training Coordinator is responsible for organizing and conducting pharmacovigilance compliance training sessions. The Pharmacovigilance (PV) Manager ensures that training materials are up-to-date and that all relevant personnel complete the training.

4) Procedure

4.1 Training Needs Assessment

1. Identify training needs based on regulatory requirements, company policies, and job roles.
2. Conduct a training needs assessment for new hires and existing staff.
3. Document the results of the training needs assessment.

4.2 Training Program Development

1. Develop a comprehensive training program covering key pharmacovigilance topics, including adverse event reporting, risk management, and regulatory requirements.
2. Create training materials, such as presentations, manuals, and quizzes.
3. Ensure training materials are reviewed and approved by the PV Manager.

4.3 Training Delivery

1. Schedule and conduct training sessions for new hires and existing staff.
2. Use various training methods, such as classroom sessions, online modules, and hands-on workshops.
3. Ensure all participants sign an attendance sheet or complete online training records.

4.4 Training Assessment

1. Administer assessments, such as quizzes or practical exercises, to evaluate participants’ understanding of the training material.
2. Provide feedback and additional training if necessary based on assessment results.
3. Document assessment results and any additional training provided.

4.5 Training Records Management

1. Maintain training records for all participants, including attendance sheets, assessment results, and training certificates.
2. Ensure training records are stored securely and are easily accessible for audits and inspections.
3. Update training records regularly to reflect completed training sessions and any required refresher courses.

4.6 Continuous Improvement

1. Regularly review and update the training program to incorporate new regulatory requirements, company policies, and best practices.
2. Solicit feedback from training participants to identify areas for improvement.
3. Implement changes to the training program based on feedback and regulatory updates.

5) Abbreviations, if any

PV – Pharmacovigilance, SOP – Standard Operating Procedure

6) Documents, if any

Training needs assessment documents, training materials, attendance sheets, assessment results, training certificates.

7) Reference, if any

ICH Guideline for Good Clinical Practice, FDA Guidance for Industry – Good Pharmacovigilance Practices, EU Guidelines on Good Pharmacovigilance Practices (GVP) Module I – Pharmacovigilance Systems and Their Quality Systems.

8) SOP Version

Version 1.0