Pharmacovigilance Auditing

• Qualifications and responsibilities according to GVP Module IV
• Conducting effective interviews
• Effective auditing of PV documents, contracts, and SDEAs
• Expectations of an auditor and inspector
• Risk-based audit strategy - planning, scheduling, and conducting

Who should attend

In just 1.5 days, our compact, interactive training programme will fully prepare you to conduct sound Good Pharmacovigilance Practice (GVP) audits.

After covering the basics of EU regulation, the first day focuses on the key tasks of the auditor: Conducting interviews with PV responsibilities or managers and reviewing various PV documents, contracts, and safety data exchange agreements (SDEAs)..
Day 2 begins with a holistic view of all the areas that need to be assessed in a PV audit. Different strategies will be discussed depending on who is auditing whom and the risk-based approach to PV audits will be trained.

During the training our qualified experts will answer many other additional questions such as:

• Where can I find supporting material such as checklists, templates, and questionnaires?
• What are the expectations of an inspector regarding the planning, execution, and documentation of an audit?

Take advantage of this compact online training course and conduct future pharmacovigilance audits safely, independently and successfully! Consolidate what you have learned and learn how to apply it directly in practice with the two included workshops.
After the seminar, you will be able to...

• accompany and conduct pharmacovigilance audits according to the latest regulations.
• conduct targeted and effective interviews.
• understand pharmacovigilance contracts and key pharmacovigilance documents in detail.
• develop risk-based audit strategies and audit plans.