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.

    Sobre este white paper

    Temas clave cubiertos en este recurso

    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.

    Lo que aprenderás

    Puntos clave de este documento

    • 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

    Sobre el autor

    Almudena del Castillo
    Almudena del Castillo

    Division Head Vigilance

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

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    Pharmacovigilance services

    Fortalece tu sistema de Farmacovigilancia

    QbD Group ofrece una gama completa de servicios de Farmacovigilancia para asegurar que tus productos cumplan con los estándares de cumplimiento y salvaguarden la seguridad del paciente.

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