SOP for Training Program in Pharmacovigilance

Purpose

This SOP outlines the process for designing, implementing, and sustaining a robust pharmacovigilance training program. The goal is to ensure that all relevant personnel have a comprehensive understanding of pharmacovigilance standards and practices.

Scope

This SOP encompasses all staff engaged in pharmacovigilance activities or requiring training related to pharmacovigilance procedures and regulations.

Responsibilities

The Training Coordinator is tasked with creating and implementing the training program.

All personnel must complete the assigned training and apply the acquired knowledge in their respective roles.

Procedure

1. Training Needs Assessment

• Identify training requirements based on individual job functions, roles, and regulatory standards.
• Conduct a gap analysis to evaluate current skills and knowledge against necessary competencies.
• Incorporate various training methods, such as workshops, e-learning modules, and hands-on sessions.

2. Development of Training Materials

• Develop comprehensive materials covering pharmacovigilance regulations, guidelines, and internal protocols.
• Ensure materials are current and incorporate updates from regulatory requirements and industry standards.
• Use diverse training methods, including workshops, e-learning modules, and practical sessions.

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3. Implementation of Training Program

• Plan and deliver training sessions for all relevant staff.
• Include pharmacovigilance training in the onboarding process for new hires.
• Provide regular refresher courses and ongoing training to address regulatory updates or procedural changes.

4. Evaluation of Training Effectiveness

• Measure the training program’s success using quizzes, assessments, and feedback surveys.
• Analyze results to pinpoint areas needing further training.
• Adapt the program based on feedback and evaluation outcomes.

5. Documentation and Record Keeping

• Maintain detailed records of training activities, including attendance, materials, and assessment outcomes.
• Securely store training records and ensure easy accessibility for audits and inspections.
• Update training records promptly to reflect completed sessions and certifications.

Abbreviations

PV: Pharmacovigilance

Documents

Training needs assessment forms

Training materials

Attendance logs

Assessment results

Feedback surveys

References

EU Good Pharmacovigilance Practices (GVP) Module I

ICH E2E Pharmacovigilance Planning

Revision History

Nil

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