Two-Day Advanced Virtual Course on Pharmacovigilance Audit and Inspections: Review EMA and FDA Requirements for Risk-Based Audits of PV System and Quality System – April 27-28, 2022 –

DUBLIN–(BUSINESS WIRE)–The “Advanced pharmacovigilance audits and inspections” training has been added to from offer.

This two-day conference-workshop will review the EMA and FDA requirements for risk-based audits of the PV system and quality system.

The PV Audit Strategy Planning course will provide an overview of the European Medicines Agency (EMA) Guideline on Good Pharmacovigilance Practice (GVP), Module IV requires that system risk-based audits quality is carried out at regular intervals to ensure that it complies with established quality requirements and to determine its effectiveness.

It includes the 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 medicines globally.

The risk-based audit strategy required by law must cover all PV processes and tasks undertaken or delegated to other departments, MAH affiliates and third parties such as distributors, external service providers, partners (the PV Universe) . The PV audit strategic plan is used to prepare the PV audit program, i.e. the annual PV audit schedule.

The course will focus on designing the PV audit strategy, identifying PV processes and entities subject to PV audit (defining the PV audit universe), developing the assessment methodology risks, the development of procedures/tools to monitor PV processes and activities, and the implementation of the PV audit strategic plan. In addition, it will examine the methods of quality control and management of third parties performing photovoltaic activities.

Learning objectives

At the end 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 strategic PV audit plan, which includes the following processes:

    • Develop a high-level PV audit strategy

    • Identify PV activities and processes subject to PV audit

    • Develop risk assessment criteria

    • Identify the universe of the PV audit – entities subject to the PV audit

    • Categorize entities subject to PV audit

    • Perform risk assessments

    • Prioritize entities to be audited based on relative risk

    • Prepare a 3-5 year PV audit plan

    • Identify procedures/tools to monitor third party PV quality

Who will benefit

This course is designed for individuals with some PV experience who are responsible for developing, maintaining, updating and/or revising the strategic PV quality system audit plan, risk assessment and/or annual schedules PV audit. It is also beneficial for personnel responsible for quality monitoring of third parties conducting photovoltaic activities.


Day 1

Presentations (12:30 p.m. – 12:45 p.m. EDT)


ICH-Guidance US/EU/Japan

ICH Q10 – Pharmaceutical Quality System

  • Product lifetime

  • Resources for monitoring 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 (31 MARCH 2017)

  • The main body covers the PV quality management system, including quality assurance

  • Annex G – Quality system:

Audit schedules

List of audits performed and completed

Significant CAPAs

  • QA Program Background and Design (12:45 p.m. – 2:00 p.m. EDT)

Strategic level – Plan to cover:

  • All pharmacovigilance activities

  • The Quality Management System (QMS) for pharmacovigilance activities

  • Interactions with other departments of the company, if applicable (BPF, Regulatory Affairs)

  • Pharmacovigilance activities carried out by affiliated bodies

  • Pharmacovigilance activities carried out by third parties

Strategic level

  • Service level agreements – outline

  • SDEA

  • Key Performance Indicators (KPIs)

Planning at the tactical level

Tactical aspects

Operational level

Pre-audit questionnaires

BREAK (2:00 p.m. – 2:15 p.m. EDT)

Case Study/Exercise with Questions and Answers (2:15 p.m. – 3:30 p.m. EDT)

Implementation of a PVQA audit program

  • Exercise – Design a QA audit program for company A

  • A few questions to consider

End of Day 1 (3:30 p.m. EDT)

Day 2

Day 1 Q&A Session (12:30 p.m. – 1:00 p.m. EDT)

PV Inspections (1:00 p.m. – 2:30 p.m. EDT)

  • EU GVP Module III – PV Inspections (16SEP2014)

  • EMA Remote PV Inspections – During Crisis Situations (SEP2020)

  • MHRA advice on remote inspections

  • Routine inspections

  • Pre-authorization inspections

  • “For cause” inspection

  • Preparing for a PV Inspection

  • Tools

  • The inspection checklist (plan) should cover

  • Document request form

  • 2020 MHRA Symposium Metrics, London

  • SMART answers when writing CAPAs

Audit and Inspection Results (2:30-2:45 p.m. EDT)

  • Questions to consider

  • Case study 1

  • Case Study 2

  • Case Study 3

Q&A session (2:45 p.m. – 3:30 p.m. EDT)

Certificate of Completion for 2 Days Online Virtual Training on Advanced Pharmacovigilance Audits and Inspections

For more information on this training, visit

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