Pharmacovigilance Audit MasterClass - US edition

03-04 June, 2026

Pharmacovigilance audits are more than a regulatory obligation

Through practical examples, live discussions, and scenario-based exercises, attendees will build confidence in auditing core and supporting PV processes, including PSMF and QPPV oversight

03-04 June, 2026, Virtual

Time Zone: Eastern Standard Time (EST) / UTC05:00

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Key learnings

Audit Types

Review And Types Of Pv Audits

An Audit Agenda

Practical Examples For Building An Audit Agenda

Issues

Importance Of Communication And Mitigating Issues

World of PV

Artificial Intelligence In The World of PV Audits

Trusted by over 17,000 delegates across leading companies

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Overview

Pharmacovigilance audits are more than a regulatory obligation. They are a strategic tool to strengthen your safety system and prevent inspection surprises. This two-day interactive masterclass walks participants through the full PV audit lifecycle, from planning and preparation to audit conduct, reporting, and managing critical findings. Through practical examples, live discussions, and scenario-based exercises, attendees will build confidence in auditing core and supporting PV processes, including PSMF and QPPV oversight.

With a strong focus on real-world challenges, common inspection findings, and the evolving role of Artificial Intelligence, this course equips professionals with the tools to deliver audits that are structured, purposeful, and inspection-ready.

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Trainer

Natasha Mihajlovic

Natasha is an experienced pharmacovigilance and quality professional with over 28 years in the life sciences industry. A Qualified Person for Pharmacovigilance (QPPV), Certified Lead Auditor, and Trainer, she has conducted more than 300 audits since 2005 across global pharmaceutical organisations, and over 100 gap analyses of PSMFs and PV systems.

Natasha is a member of the UKAI Advisory Board and Chair of the UKAI Life Science Working Group, PV Lead for PIPA AI Specialist Group and contributes to the Blum Al Institute, advancing responsible AI practices in healthcare. Holding an MSc in Pharmacovigilance and a Diploma in Artificial Intelligence, she combines deep regulatory and operational expertise with emerging insights into AI governance and assurance. For the PSMF Masterclass, Natasha brings a unique perspective that bridges traditional pharmacovigilance systems with modern digital assurance, highlighting how evolving technologies intersect with regulatory expectations and quality oversight.

Kamila Erbanova

Kamila is an experienced pharmacovigilance (PV) and quality professional, and a certified Lead Auditor. She has an in-depth knowledge and experience in not only conducting and hosting audits but also supporting PV inspections from various health authorities, thus understanding different requirements and preferences. In addition, she has been PV System Master File (PSMF) Coordinator and/or supporting PSMF projects, process improvements and gap analysis reviews.

She is coming from a background of PV Quality Assurance operations, with focus on implementation and management of Quality Management System processes, inspection readiness activities, vendor management and oversight, and an extensive experience with PSMF maintenance and process improvement. Having worked on the side of service providers with many clients on their PSMFs, using different templates, processes and complying with global as well as various local requirements, she brings to the table a fresh perspective on the different approaches companies can take, while
remaining compliant and making their PSMF a useful tool, instead of a burden.

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Reasons to attend a masterclass

Practical knowledge

Venture into undiscovered territories and gain inspiration through collaboration

Interactivity

Boost your professional skills by directly engaging with domain experts

World-class trainers

Gain value and learn from the best instructors

Networking

Build a top-notch community and advance your career

Who should attend img WHO SHOULD ATTEND

-PV auditors
-GxP/PV quality assurance managers
-Senior PV specialists
-Pharmacovigilance compliance leads
-QPPVs and deputy QPVVs
-PV operations managers
-Medical safety physicians
-Regulatory affairs professionals
-Vendor oversight/alliance management leads
-Inspection readiness leads

Ticket options for you

Full event
pass

Team participation?

*minimum of 10 participants

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Testimonial

Our success stories

"High attention to detail in course content and very well delivered"

Simon Halsey

Product Development Manager
Essentra Packaging
United Kingdom

Our success stories

"Very good training led by two knowledgeable and open experts. Excellent insight given on many complex topics. Interactive and highly useful"

Aurelie Vivicorsi

USP PD Team Manager
Celonic AG
Switzerland

Our success stories

"Great course, impressed with the knowledge of the trainers and ability to answer wide variety of questions!"

Emilia Szwej

Manager, Senior Investigator
MT Sword Laboratories (BMS)
Germany

About GLC

Global Leadership Conferences began as an ambitious dream by three founders ten years ago. Today its an international series of interactive events, exploring the hottest topics in critical fields. Each year, thousands of professionals join us to challenge the status quo and learn innovative ways to create new solutions in Finance, Pharmaceutical, HR, Health & Safety, and Energy.

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