audit inspection pharmacovigilance



The training course “Audit and Inspection in Pharmacovigilance” will help the participant understand how well-designed and well-conducted pharmacovigilance audits allow pharmaceutical companies to identify any existing gaps or risks in their PV systems and procedures and to define activities and priorities for the continuous improvement of their PV quality systems. This has the aim to ensure compliance of the PV system to national and international legislation and recognized standards and to be ready to face GVP regulatory inspections. during the course, a deep review of the most important PV processes and interactions between internal and external stakeholders will outline more common areas of improvements according to auditors/inspectors expectations.


Learning objectives of the course audit and inspection in pharmacovigilance

Understand the specific requirement of a Pharmacovigilance Quality System and implement or improve this process in their own organisation

Learn the key phases of the pharmacovigilance audit both as an auditor and as an auditee

Focus on most important interactions of a Pharmacovigilance System and processes usually reviewed during GVP audit and inspections

Learn how to approach and face up a GVP audit

Learn how to prepare organization for a GVP inspection understanding the regulatory expectations


Times are UTC +1 (Rome time)

April 4, 2023

9.00 Introduction to the course

9.10 What are the main regulatory requirements and the organization of the PV System?

  • Main requirements and key points
  • Key PV processes
  • Interactions with other company departments
  • Q&A time

10.50 Coffe Break

11.10 GVP Audit

  • Regulatory requirements
  • Risk based approach
  • Audit announcement, preparation and conduction
  • CAPA plan monitoring
  • KPIs on audit activities

12:40 Q&A Time
13:00 Closure of day one


April 5, 2023

9.15 Focus on GVP Inspection requirements

  • Regulatory requirements
  • Risk based approach
  • Inspection announcement
  • Q&A Time

10.30 Coffee Break

10:50 GVP inspection readiness

  • Key points in the preparation of inspection
  • Interaction with other company departments
  • GVP inspection days

11.30 What are the main inspector’s expectations?

  • Sharing of most common finding and experience
  • Discussion

12:15 Key takeaways
12:30 Closure of the course

For professionals working in the following areas:
• Pharmacovigilance
• Drug Safety and Risk Management
• Regulatory Affairs
• Clinical Research
• Quality and Compliance

Patrizia Rotunno
The speaker is a pharmacovigilance expert dealing with Pharmacovigilance Systems since more than 20 years. With a Regulatory Affairs background she has been QPPV of a medium sized company having the opportunity to manage almost all pharmacovigilance processes within pharmacovigilance system and its quality system.
Five years ago, she started working as Pharmacovigilance Consultant to assist clients improving compliance with the pharmacovigilance legislation and Good Vigilance Practices, from start-up phase of a pharmacovigilance system to creation and/or review and management of specific pharmacovigilance documents. In the last five years she has also conducted several GVP audits to client’s pharmacovigilance systems or to service providers/business partners on behalf of the clients and she has supported some pharmaceutical companies in preparing and facing up to GVP inspections.

€ 750 early bird fee, expires March 4, 2023
€ 900 full price
VAT not included. Discounts are not cumulative. Please inquire for discounts for multiple registrations.

Advance payment is required with respect to the event date by bank transfer to BANCO BPM Spa – Firenze, IBAN IT81P0503402801000000007431, Bic/SWIFT BAPPIT21N25 made payable to Pharma Education Center S.r.l., Via dei Pratoni 16, 50018 Scandicci (FI), VAT number 02173670486, specifying event title along with name and surname of the participant enrolling. Attendance to the event will be allowed upon payment received. Invoice of payment will be issued after the second half of the month after the course. For further information and/or further assistance please contact (+39) 055 7224179 or email:

If the minimum number of participants is not reached, Pharma Education Center reserves the right to cancel or schedule the event for another date. Formal communication will be given within 5 days before the event date. In this case Pharma Education Center will refund the registration fee in full and without additional charges. Alternatively, the participant can request a spendable coupon for participating in another PEC event scheduled in the current year.

In order to cancel enrolment to a event, please email within 2 weeks before the starting date of the event. Once this term will be expired, the entire fee will be charged.

It is possible to replace a participant attendance without additional cost, simply by contacting It is asked to notify the participant replacement request within 5 days before the starting date of the course/event, specifying the full name and surname of the enrolled participant as well as the full name and surname of the substitute.

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Via Dei Pratoni, 16 – 50018 Scandicci (FI)
Tel. (+39) 055 0465181