PSMF - System Master File From A - Z MasterClass - EU edition
17-19 March, 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.
17-19 March, 2026, Virtual
Time Zone: UTC/GMT+1 /CET
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.
#masterclass #glceurope #pharmaonlinetraining #globalleadingconferences #PVsystemmasterfile
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.
She has supported the development, maintenance, and continuous improvement of Pharmacovigilance System Master Files (PSMFs) ensuring alignment with GVP requirements and inspection expectations. Her background includes extensive experience in aggregate report preparation, signal and risk management, and quality management system implementation. For the PSMF Masterclass, she offers a practical perspective grounded in real-world system oversight highlighting how an effective PSMF serves not just as a regulatory deliverable, but as the backbone of pharmacovigilance governance and continuous improvement.
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
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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