Online Webinar | September 3, 2026 | 15:00 CEST
Choosing a computerised system for pharmacovigilance can look straightforward on paper. Vendors present polished demos, workflows seem to fit, and implementation plans promise a smooth transition.
But what happens after the contract is signed?
The real challenges often appear later — when legacy data needs to be migrated, integrations have to work in practice, system changes require revalidation, or an auditor starts asking questions about your processes and controls.
On September 3 at 15:00 CEST, DrugCard is bringing together two experienced PV and technology professionals, Dmytro Horilyk and Jan Kolouch, for a practical discussion about what organisations should consider when selecting and implementing computerised systems in pharmacovigilance.
This webinar will go beyond the standard vendor demo and focus on the issues that can have the biggest impact on your PV operations after go-live.
What We Will Cover
The discussion will focus on five areas that are often underestimated during system selection and implementation.
Choosing the right vendor and solution
Every organisation has different processes, regulatory requirements, team structures, and business priorities. We will discuss how to evaluate vendors and solutions against the actual business case, rather than choosing based on a successful demo or an impressive feature list.
Why the demo always works — and real life doesn’t always follow
A demo is designed to show the system at its best. Your first real case may tell a very different story. We will look at the gap between a controlled demonstration environment and day-to-day PV operations — including workflows, edge cases, user requirements, and the practical questions that should be asked before making a decision.
Data migration: getting legacy data into the new system
Moving from one system to another is not simply an IT exercise. Legacy data can affect workflows, reporting, compliance, data integrity, and the way your team operates long after migration is complete. We will discuss what organisations should consider before migration and what it really means to live with migrated data after go-live.
Integrations, maintenance, upgrades and revalidation
The implementation budget is only part of the picture. Integrations need to be maintained. Systems need upgrades. Processes may change. And in a regulated environment, changes can trigger validation and revalidation activities. We will explore the ongoing costs and responsibilities that are easy to overlook when comparing vendors and building an implementation plan.
What auditors actually ask about computerised systems
Computerised systems are not just about functionality. They are part of a regulated PV environment, which means organisations need to demonstrate that systems are appropriately controlled and maintained. The webinar will cover the types of questions auditors may ask about computerised systems, processes, data integrity, validation, and change management — and how to prepare for them before go-live rather than during an inspection.
Speakers
Dmytro Horilyk — CEO, DrugCards OÜ
Dmytro Horilyk is the CEO of DrugCards OÜ, focused on driving innovation in pharmacovigilance through AI-powered technology and automation. With a background in computerised system validation (CSV) and data integrity, he leads DrugCard’s growth and product vision, helping organisations make drug safety processes more efficient, reliable, and audit-ready.
Jan Kolouch — CEO & Co-Founder, Next PV Services | EU QPPV & Strategic PV Advisor
Jan Kolouch is an experienced pharmacovigilance professional, EU QPPV, and Strategic PV Advisor with a strong background in safety operations, compliance, and PV systems. As CEO & Co-Founder of Next PV Services, Jan helps organisations build practical, reliable, and tailored pharmacovigilance solutions, bringing together operational PV expertise, regulatory requirements, and the realities of implementing and maintaining PV systems.
Why This Matters
Selecting a computerised system is a long-term decision. The vendor relationship, data, integrations, validation requirements, upgrades, and operational processes can remain part of your PV landscape for years after the initial implementation. That is why a successful demo should be only the starting point of the evaluation. The most important questions often begin after the demo:
– What happens when the system meets our real data?
– What will this integration require six months from now?
– What will an upgrade mean for our validated state?
– Who owns the process when something goes wrong?
– And will we be ready to answer an auditor’s questions?
This webinar is an opportunity to hear practical lessons from professionals who work at the intersection of pharmacovigilance, technology, compliance, and system implementation — and to look beyond what vendors typically show during a demo.
Registration is free. Join us on September 3 at 15:00 CEST.
