Integration of Pharmacovigilance Systems in EU: Challenges and Opportunities
Pharmaceutical legislation provides a legal framework, to ensure the
availability of acceptably safe, effective enhancement and high-quality
medicines to patients. Within this framework, marketing authorization
holders (MAHs) are requested to establish and maintain pharmacovigilance
(PV) systems. These systems should be capable of detecting,
assessing, understanding, and preventing adverse effects or any other
possible drug-related problem [1].
In our setting, we merged four different PV systems in a new Headquarter
(HQ)-Affiliate model in the European Union (EU) context. This
occurred through a deep and comprehensive due diligence, with subsequent
harmonization and enhancement of procedures and tools in order
to comply efficiently with the legal framework.
This integration aimed to establish of a clear, transparent, and centralized
organizational structure with peripheral dependencies at the country
level. A functional reporting and management system has been developed
in order to ensure efficient data collection and processing, as
well as the detection, assessment, understanding, mitigation and communication
of medicinal product risks, in accordance to EU regulations
and international requirements.
The PV systems integration offered the opportunity to enhance quality
and compliance of processes and to centralize Companies’ relationships
with regulators and commercial partners.
The principal aim was the rationalization and strengthening of the PV
system, with a centralized HQ overview supported by local Affiliates.
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