The Risk-Based Approach to Pharmacovigilance Audits - A Practical Approach to Design and Implementation

European Medicines Agency's (EMA) Guideline on good pharmacovigilance practices (GVP), 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 has to cover all PV processes and tasks undertaken by or delegated to other departments, Marketing Authorization Holder affiliates, and third parties such as distributors, external service providers, licensing partners. In other words, has to cover all PV Universe. The PV Audit Strategy Plan is used to prepare the PV audit program, i.e. annual PV Audit Schedule. Using risk-based approach to develop an audit strategy, companies can conform to the regulatory requirements and business needs. But the questions remain: How to do it? Where to start? How to improve? What are the best industry practices?

In this two day workshop, we will review the legal GVP requirements (predominantly European, FDA and Arab League) regarding risk-based audits of the PV system and quality system. The course will focus on:

The design of the PV audit strategy and tactical PV audit plan/schedule.
Identification of the PV processes and entities subject to PV audit (understanding how to define the PV audit universe)
Development of risk assessment methodology for various aspects of PV world (for instance computerized systems, market research, patient support programmes, vendors, processes etc)
Development of procedures/tools to monitor PV processes and activities, and implementation of the PV audit strategy plan.

Learning Objectives:
Upon completing of this course, participants should be able to:

Understand the legal requirements and health authority expectations for a risk based audit program and current interpretation.
Plan, develop and implement the PV Audit Strategy Plan, which includes the following processes:
Identify the PV activities and processes subject to PV audit
Identify the PV audit universe – entities subject to PV audit
Categorize the entities subject to PV audit
Develop risk assessment criteria specific to PV areas
Perform risk assessments
Develop a high-level PV audit strategy
Prioritize entities for audit according to relative risk
Prepare a 3-5 year PV audit plan
Identify procedures/tools to monitor PV quality of third parties
Who will Benefit:
This course is designed for people with some PV experience and tasked with developing, maintaining, updating and/or reviewing the PV quality system audit strategy plan, risk assessment and/or the annual PV audit schedules. It is also beneficial for staff responsible for the quality oversight of third parties conducting PV activities.

The following personnel will benefit from the course:

PV Quality Assurance Staff
PV Compliance professionals
Quality auditors
Pharmacovigilance Auditors
Relevant Pharmacovigilance Staff
PV Service Provider Relationship Managers
MAH Affiliates responsible for Pharmacovigilance