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Ensuring the safety and efficacy of medicines both before and after marketing authorisation is a basic, fundamental responsibility, and this process is governed through the mandatory implementation of Good Pharmacovigilance Practices (GVP).
Adherence to GVP and other regulatory requirements is monitored through auditing and/or inspections, and that requires the specialist role of Good Pharmacovigilance Practice (GVP) auditor, responsible for the comprehensive review and assessment of drug safety data and PV systems.
GVP Auditors are extensively trained, and updated, to ensure compliance with international regulatory standards, both to safeguard public health and safety, and companies from the potential legal and financial repercussions of non-compliance.
Tailored training solutions: Designed to meet companies’ specific needs, ensuring compliance with international and locally applicable regulatory standards.
Defining Audit Objectives and Scope: Training on how to set clear, achievable objectives for each audit, and how to define the audit scope to ensure all the critical aspects of pharmacovigilance are covered, including specific processes, departments, and data systems.
Audit Checklist Development: Guidance on creating comprehensive audit checklists tailored to GVP requirements, covering areas such as adverse event reporting, risk management plans, and safety signal detection.
Effective Audit Techniques: Instruction on various audit techniques, including document review, data verification, process observation, and conducting interviews with key pharmacovigilance personnel to gather in-depth insights into the PV system's effectiveness.
Identifying and Documenting Findings: Training on identifying compliance gaps, non-conformities, and best practices during the audit, and effectively documenting these findings with clear evidence and context.
Communicating Audit Results: Strategies for communicating audit findings to stakeholders, including the preparation of clear, concise, and actionable audit reports, and conducting debriefing sessions with audited entities to discuss findings, implications, and potential corrective actions.
iVigee’s GVP Auditor Training team includes experienced professionals from Marketing Authorization Holders (MAHs), regulatory authorities, and PV service providers, offering a wide and balanced perspective on pharmacovigilance practices and practical GVP audit requirements. And through our world leading iViReg global Regulatory Intelligence platform our training incorporates the latest regulatory standards and expectations from over 90 countries.
All our training modules are fully customisable, designed to meet the specific needs of any audit scenario. This flexibility ensures that participants are equipped with the knowledge and skills relevant to their unique operational contexts. They include practical exercises and case studies derived from real-world scenarios, enhancing understanding and the application of GVP principles in real audit situations.
iVigee’s training methodology emphasizes interaction and engagement, facilitating a deeper understanding of complex GVP concepts through group discussions and Q&A sessions. Participants receive certification upon completion, recognising their competency in GVP auditing, which can enhance their professional development and credibility in the field.