PV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach to Design and Implementation (San Francisco, CA - June 21-22, 2018) - ResearchAndMarkets.com

The European Medicines Agency's Guideline on good pharmacovigilance practices, Module IV requires that risk-based audits of the quality system be performed at regular intervals to assure that it complies with the established quality requirements and to determine its effectiveness. It includes audit of the pharmacovigilance system which is covered by the quality system.

The GVP Modules are applicable to EU-based companies and any company marketing medicinal products on a global basis. The legally required risk based audit strategy shall cover all PV processes and tasks undertaken by or delegated to other departments, MAH affiliates, and third parties such as distributors, external service providers, partners. The PV Audit Strategy Plan is used to prepare the PV audit program.

In this two day workshop conference we will review the EMA and FDA requirements regarding Risk Based Audits of the PV system and Quality System. The course will focus on the design of the PV audit strategy, identification of the PV processes and entities subject to PV audit, development of risk assessment methodology, development of procedures/tools to monitor PV processes and activities, and implementation of the PV audit strategy plan. Additionally, we will review methods of quality oversight and management of third parties performing PV activities.


1. Review of FDA and EMEA requirements for risk based PV audits

2. The pharmacovigilance system and the quality system

3. Strategic level audit planning

4. Hands on exercise

5. PV activities and processes subject to PV audit

6. Risk assessment criteria

7. The PV audit universe all entities subject to PV audit

8. Safety data exchange agreements and vendor contracts

9. Categorization of the entities

10. Risk assessments

11. Prioritization of entities for audit according to relative risk

12. 3-5 year PV audit plan

13. Hands on exercise

14. Procedural documents

15. Identify procedures/tools to monitor PV quality for oversight of third parties

For more information about this conference visit https://www.researchandmarkets.com/research/k5td2t/_pv?w=4

Back to news