Basics of Post-Marketing Pharmacovigilance and the Beginner PV Auditor

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Course Description

As of 2012, the “gold” standard of pharmacovigilance (PV) and adverse event (AE) reporting on a global level is based on the European Medicines Agency (EMA) PV Modules, which require that Quality Assurance (QA) be part of the quality management system (QMS), and that PV audits be performed at various levels and at varying sites. Although most Good Clinical Practice (GCP) experts are familiar with pre-marketing drug safety, there is a difference to post-marketing PV and the associated activities.

This is an introductory course for those unfamiliar with the EMA PV Modules or global reporting requirements. The basics of EMA (and FDA) expectations on the receipt, processing, reporting, and management of AEs for marketed products (drug and device), and how to prepare for auditing these systems will be presented. Learners will be shown the basic concepts of reportable events, timelines of reporting, what the global PV department is responsible for, and the audit process to be applied for both systematic internal audits as well as at affiliated offices and PV vendors. The course will include presentations, discussions, and problem-solving techniques using case studies applicable to both drug and device marketed products. Exercises are designed to help you understand what the PV process actually is and how to apply an auditing perspective.

Learning Objectives

  • Recognize post-marketing PV expectations and compliance on a global level
  • Review the EMA PV Modules at the basic level
  • Determine PV reporting responsibilities applicable to global PV submissions
  • Apply basic auditing concepts to assess PV compliance

Who Should Attend

  • Heads of Pharmacovigilance Quality Assurance Departments
  • Auditors transitioning into pharmacovigilance auditing
  • Drug Safety Staff
  • Quality Assurance Staff responsible for pharmacovigilance self-inspections
  • Medical Information Staff
  • Safety Physicians


The course will be led by one of the following instructors:

Sharon Donatucci

Vaska Tone

Click here for complete trainer biographies

Course Outline

Day One: 8:30 a.m. – 5:00 p.m.

  • EMA PV Modules and FDA Safety Reporting Basics
  • Systems Used in PV Data Gathering and Individual Safety Case Reporting (ICSRs)  
  • Understanding Periodic Safety Update Reports (PSURs)  
  • Eudravigilance & Signal Detection  
  • Hands-on Exercise: Reviewing “AE Source Documents” & Resulting ICSRs
  • Reviewing Periodic Safety Update Reports  

Day Two: 8:30 a.m. – 5:00 p.m.

  • PV Audit Plans, Scope, and Agendas
  • PV Audit Questionnaires and Checklists  
  • Current EMA/FDA PV inspection findings  
  • Hands-on Exercise: Drafting the audit agendas and checklists for: System Audit, Affiliate Audit, Vendor Audit

Registration Fees

Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.

Special rates are available for multiple attendees from the same organization.  Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings.     

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Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 15 hours (1.5 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-18-003-L01-P. Released: 4/18.


Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.