Advanced Post-Marketing Pharmacovigilance Auditing

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Course Description

The European Medicines Agency’s (EMA) post-marketing Pharmacovigilance (PV) regulations known as the EMA PV Modules are designed with the expectation that companies adhere to this new global “gold” standard regarding the receipt, processing, managing, maintenance, and submissions of Adverse Event (AE) data to the relevant health authorities. Not only are these standards applicable to EU-based companies, but any company marketing products (drugs or devices) on a global level. We will review the FDA and EMA expectations, and apply them to the various PV audits.

This course is designed for those that already have some post-marketing PV experience (either experienced auditors or practical hands-on PV staff). Learners will receive training on how to audit PV at the local level, but to do it with a global perspective. The course will focus on understanding PV agreements, and reporting to health authorities and the relevant auditing mechanisms, including the generation of the annual audit plan based on a risk assessment; generating audit agendas once the plans are put into play; understanding Safety Data Exchange Agreements (SDEA); understanding Periodic Safety Update Reports (PSURs); requesting pre-audit information of PV departments in-house, at a license/marketing partner, vendor, or distributor; and generating the correct categorization of findings for the audit reports.

Learning Objectives

  • Determine whether Safety Data Exchange Agreements are adequate
  • Determine whether PSURs are covering the correct information and timeframes
  • Prepare annual PV audit plans
  • Prepare relevant PV audit agendas based on the type of PV audit required
  • Request relevant PV data as part of the audit preparation activities
  • Conduct PV audits with a focus on different PV topics
  • Prepare audit findings and categorizations

Who Should Attend

  • Heads of Pharmacovigilance Quality Assurance Departments
  • Pharmacovigilance Auditors
  • Heads of Pharmacovigilance Departments
  • Relevant Pharmacovigilance Staff
  • PV Safety Scientists
  • Quality Assurance Staff responsible for pharmacovigilance self-inspections


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 & FDA Safety Reporting: When and How?
  • Who to Audit: Internal Systems, Affiliates, License Partners, Vendors, and Distributors
  • PV Audit Plans, Scope and Agendas  
  • Understanding Different Contracts/Agreements  
  • Hands-on Exercise: Designing an annual audit plan – risk based; Preparing the correct scope for the various PV audits; Preparing the correct audit agenda (2, 3, or 4 day audits); Review of various contracts (determine what is wrong with them)

Day Two: 8:30 a.m. – 5:00 p.m.

  • Auditor Preparation: PV Audit Questionnaires & Checklists
  • PV Audit Conduct  
  • Hands-on Exercise: Use of the pre-audit questionnaire –review of several examples; Use of PV Audit Checklists; Follow the AE: Review of PV tracker, source document(s), cases MedWatch/CIOMS), submissions; Role Playing

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#: 0778-0000-18-002-L01-P. Released: 7/18.


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