Building a Global Pharmacovigilance Framework for Seamless EU Entry and Worldwide Expansion

挑战

As the company prepared for EU market entry with a centrally authorized product while simultaneously expanding internationally, it faced the challenge of establishing a compliant and scalable pharmacovigilance framework across multiple regions.

The organization required a centralized PV operating model capable of supporting both EU requirements and local regulatory obligations worldwide. This included coordinating activities between global PV teams, ensuring consistent communication with competent authorities, and managing collaboration with local pharmacovigilance providers across an increasing number of countries.

In addition, the company needed a framework that would remain scalable as new markets were added, without significantly increasing internal operational complexity or headcount.

方法

Developing a centralized and scalable global PV model

QbD Group designed and implemented a scalable central pharmacovigilance operating setup based in Poland, supporting both EU market entry and broader international expansion.

Our approach included:

• Development of a centralized PV system including SOPs and instructions supporting global PV operations.
• Establishment of collaboration models with local country pharmacovigilance providers (LCPPVs) across the EU.
• Support for key PV activities including QPPV oversight, Safety Data Exchange Agreements (SDEAs), periodic reconciliations, and ICSR exchange processes.
• Definition of a structured market-entry approach for new countries, including LCPPV notifications, local SOP implementation, trainings, and local audits.
• Facilitation of close collaboration between PV teams across multiple regions including Europe, China, Egypt, UAE, and Canada.

Throughout the project, QbD Group ensured alignment between global and local pharmacovigilance requirements while maintaining operational efficiency and clear governance structures.

结果

Enabling compliant global expansion through centralized PV oversight

The implemented pharmacovigilance framework enabled the client to establish a coordinated and compliant global PV model supporting continued international growth.

As a result, the company achieved:

• Regulatory compliance across global markets under one centralized PV structure.
• Positive feedback during inspections by EMA and other competent authorities.
• Improved operational efficiency and oversight through structured communication flows, reconciliations, and country trackers.
• Scalable multi-country pharmacovigilance management without increasing internal headcount.

The centralized model now provides the company with a strong foundation for sustainable global expansion while maintaining consistent pharmacovigilance quality and compliance standards.