The 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 an audit of the pharmacovigilance system which is covered by the quality system. The GVP Modules apply 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 Universe). The PV Audit Strategy Plan is used to prepare the PV audit program, i.e. annual PV Audit Schedule.

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 (define the PV audit universe), 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.

Learning Objectives:-

• 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:

  • Develop a high-level PV audit strategy
  • Identify the PV activities and processes subject to PV audit
  • Develop risk assessment criteria
  • Identify the PV audit universe – entities subject to PV audit
  • Categorize the entities subject to PV audit
  • Perform risk assessments
  • 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

Session Agenda:-

DAY 01(9:30 AM - 4:30 PM EST)

• 09.30 AM: Session Start
• Review of FDA and EMEA requirements for risk-based PV audits
• The pharmacovigilance system and the quality system
• Strategic level audit planning
• Hands-on exercise
• PV activities and processes subject to PV audit
• Risk assessment criteria
• The PV audit universe - all entities subject to PV audit
• Safety data exchange agreements (SDEAs) and vendor contracts

DAY 02(9:30 AM - 4:30 PM EST)

• Stability (shelf-life) studies
• Categorization of the entities (PV Audit Universe)
• Risk assessments
• Prioritization of entities for audit according to relative risk
• 3-5 year PV audit plan
• Hands-on exercise
• Procedural documents, e.g. SOPs
• Identify procedures/tools to monitor PV quality for oversight of third parties
• Q & A