QbD Group
    White Paper

    Scaling Pharmacovigilance in Europe

    A Practical Guide for Pharma SMEs and Biotechs

    As pharma SMEs and biotechs grow, pharmacovigilance systems that once worked well can quickly become a bottleneck. This white paper breaks down how to build a pharmacovigilance (PV) setup that scales with your business, without losing compliance or control.

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    本资源涵盖的关键主题

    Growing your product portfolio, entering new markets, or going through an acquisition all put pressure on your pharmacovigilance system. What worked at an early stage may no longer be fit for purpose when operations become more complex and distributed across multiple countries, vendors, and stakeholders.

    In this white paper, Almudena del Castillo, Head of QbD's Global Vigilance Division, shares a practical framework for scaling pharmacovigilance in Europe. From choosing the right operating model to building governance structures that hold up under regulatory scrutiny, this guide gives pharma SMEs and biotechs a clear roadmap for sustainable PV growth.

    What you'll learn

    Key takeaways from this document

    • Why scalability in pharmacovigilance matters
    • How to choose the right PV operating model
    • Why governance is the backbone of scalability
    • How to organize for scale: data, systems and people
    • Real scenarios of PV scalability

    关于作者

    Almudena del Castillo
    Almudena del Castillo

    Former QPPV · Division Head Vigilance & Country Manager Spain

    Almudena leads pharmacovigilance strategy and operations at QbD Group as Division Head of Vigilance and Country Manager for Spain, helping pharma and biotech companies build robust drug safety systems.

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    Pharmacovigilance services

    Strengthen Your Pharmacovigilance System

    QbD Group offers a full range of pharmacovigilance services to ensure your products meet compliance standards while safeguarding patient safety.

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