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European Medicines Agency Advanced Pharmacovigilance Auditing and Inspections Course: May 18th-19th, 2022 -

DUBLIN--(BUSINESS WIRE)--The "Advanced Pharmacovigilance Auditing and Inspections Course" training has been added to's offering.

This two-day workshop conference 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, it will review methods of quality oversight and management of third parties performing PV activities.

PV Audit Strategy Planning course will provide an overview of 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 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 Universe). The PV Audit Strategy Plan is used to prepare the PV audit program, i.e. annual PV Audit Schedule.


Day 1



  • ICH - Guidance US/EU/Japan

ICH Q10 - Pharmaceutical Quality System

  • Life time of a Product
  • Resources to monitor the QS

ICH Q9 - Quality Risk Management

  • Risk Management Methods and Tools
  • ICH E2- Clinical Safety Data Management
  • 21 CFR Part 314:80/81

EU GVP Module IV (R1) - PV audits (12AUG2015)

  • Risk Based approach
  • Strategic Level (2-5 years)
  • Tactical level
  • Operational level

Pharmacovigilance System Master File

  • GVP Module II - PSMF (31MAR2017)
  • Main body covers the PV QMS including QA
  • Annex G - Quality System:
  • Audit schedules
  • List of audits conducted and completed
  • Significant CAPAs
  • Background & Design of QA Programme

Strategic Level - Plan to cover:

  • All pharmacovigilance activities
  • The Quality Management System (QMS) for pharmacovigilance activities
  • Interactions with other company departments, as appropriate (GMP, Regulatory Affairs)
  • Pharmacovigilance activities conducted by affiliated organisations
  • Pharmacovigilance activities conducted by third parties

Strategic Level

  • Service Level Agreements - outlines
  • SDEA
  • Key Performance Indicators (KPI)

Tactical Level Planning

Tactical Aspects

Operational Level

Pre-Audit Questionnaires


Case study/Exercise with Q&A

  • Implementation of a PVQA Audit Programme
  • Exercise - Design a QA Audit Programme for Company A
  • Some questions to consider

End of Day 1

Day 2

Q&A session from Day 1

PV Inspections

  • EU GVP Module III - PV Inspections (16SEP2014)
  • EMA Remote PV Inspections - During crisis situations (SEP2020)
  • MHRA guidance on Remote Inspections
  • Routine Inspections
  • Pre-Authorisation Inspections
  • 'For Cause' Inspection
  • Preparing for a PV Inspection
  • Tools
  • Inspection Checklist (Plan) should cover
  • Document Request form
  • Metrics from MHRA 2020 Symposium, London
  • SMART Responses when drafting CAPAs

Audit & Inspection findings

  • Questions to consider
  • Case Study 1
  • Case Study 2
  • Case Study 3

Q&A session

For more information about this training visit

Laura Wood, Senior Press Manager
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900

Editor Details

  • Company:
    • Businesswire
Last Updated: 03-Mar-2022