PSMF - System Master File From A - Z MasterClass - EU edition

01-03 September, 2026

PSMFs purpose, structure, and regulatory requirements

The PSMF Masterclass is a practical, three day program designed to establish a strong baseline on the Pharmacovigilance System Master File and then build toward advanced, real world application.

01-03 September, 2026, Virtual

Time Zone: UTC/GMT+1 /CET

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Key learnings

PSMF Fundamentals

PSMF Fundamentals: Purpose, Structure, GVP II, and Global Compliance.

Maintenance & Control

Maintenance & Control: Practical SOPs, Versioning, Logbooks, and Audit Trails.

Inspection Readiness

Inspection Readiness: Expectations, Frequent Findings, and Prevention Strategies.

Effective Governance

Effective Governance: Global/Regional Models, QPPV Roles, and Cross-functional Partnership.

Performance & Improvement

Performance & Improvement: Utilizing Data and KPIs for PV System Optimization.

Real-World Application

Real-World Application: Hands-on Scenarios (Product Transfers, Ownership Changes).

Trusted by over 17,000 delegates across leading companies

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Overview

The PSMF Masterclass is a practical, three day program designed to establish a strong baseline on the Pharmacovigilance System Master File and then build toward advanced, real world application. Day 1 aligns everyone on the PSMFs purpose, regulatory context, and core structure. Day 2 dives into inspection focus areas, governance models, and continuous improvement with metrics. Day 3 turns learning into practice through operational workflows, complex scenarios, and case-based exercises. By the end, participants will know what a good PSMF looks like, how to maintain it, and how to navigate common pitfalls with confidence.

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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 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

-Pharmacovigilance professionals responsible for PSMF content, maintenance, or oversight
-QPPVs and PSMF Leads/Coordinators seeking clarity on governance, accountability, and inspection readiness
-PV Operations, Compliance, and Quality teams who contribute inputs to the PSMF
-Regulatory Affairs and Labelling
-Quality Assurance
-Clinical
-Medical Affairs
-Safety vendors and third-party service providers
-Local country affiliate teams managing local PSMFs or integrating with a global master file
-Project and program managers involved in PV change events such as mergers, product transfers, and system transitions

Ticket options for you

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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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