Pharmacovigilance Auditing

This event offers a combination of well-founded theoretical principles, practical workshops, and interactive discussions. To maximise your learning experience, we kindly ask you to keep your camera on whenever possible and actively participate.

After completing the seminar, you will have the opportunity to take a multiple-choice test in the Learning Space as proof of your learning progress. Upon successfully passing the test, you will receive a certificate as a "Certified Auditor for Good Pharmacovigilance Practices" in addition to your certificate of attendance.

This seminar is designed for professionals who want to plan, support and conduct pharmacovigilance audits in a structured and practical way. There are two typical career paths into PV auditing:

1. PV professionals taking on audit responsibilities
The seminar is suitable for pharmacovigilance experts, QPPVs and other professionals responsible for pharmacovigilance activities who need to audit their own organisation, service providers, partners or external processes. Many PV auditors develop their role step by step: They first support audits, take responsibility for specific audit areas and later lead audits independently. If you plan to work as an independent consultant in the future, a documented record of successfully completed PV audits can serve as an important professional reference.

2. GxP auditors expanding into pharmacovigilance
This seminar is also aimed at experienced GxP auditors who will be expected to conduct or support audits in pharmacovigilance. A sound understanding of the fundamentals of pharmacovigilance is essential for this role. If you do not yet have sufficient PV knowledge, we recommend attending our two-day seminar “An Introduction for Pharmacovigilance Managers” before taking part in this course.
For a combined booking at a reduced rate, please contact us directly.

The European Medicines Agency and national competent authorities such as the BfArM publish templates that illustrate how pharmacovigilance systems, processes and findings may be structured, assessed and documented during regulatory inspections.

During the seminar, we will discuss how these materials can support audit preparation and help auditors identify relevant areas, including QPPV responsibilities, the PSMF, SOPs, contracts and safety data exchange agreements, reporting processes, signal management, quality management and CAPA.

Regulatory inspections are not the same as internal, partner or service provider audits. However, authority templates provide valuable reference points for understanding broader expectations and defining a risk-based audit scope. They support the audit process but do not replace professional judgement or the applicable GVP requirements.

For further background, please refer to the EMA’s overview of pharmacovigilance inspection procedures for human medicines and the BfArM’s information on pharmacovigilance inspections. Te BfArM page is in German, but the linked documents are available in English.