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Scaling Pharmacovigilance in Europe: A Practical Guide for Pharma SMEs and Biotechs

Want to receive clear, experience-based guidance on how to manage pharmacovigilance (PV) across Europe without overextending your resources?

Watch our webinar on demand and learn how to balance global consistency with country-specific requirements, meet strict European timelines with lean teams, and apply practical, proven strategies that strengthen both central oversight and local execution.

Register here

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On demand

1h

Pharma

English

Pharmacovigilance

Balancing global efficiency with local compliance

Pharmacovigilance is a global responsibility, but for small and mid-sized companies, it often feels overwhelming. Limited teams, tight budgets, and the absence of local affiliates can make staying compliant a constant challenge.

In this session, we’ll show you how to do more with less:

• Capture the efficiencies of centralized processes while addressing country-specific requirements
• Right-size your operating model without overbuilding internal infrastructure
• Strategically leverage partners (EU-QPPV, local RPs, literature screening, case processing) to stay compliant

Expect a practical, hands-on discussion packed with tools, quick wins, and coordination strategies you can use immediately. We’ll share real case studies of SMEs that have successfully aligned global PV systems with local regulations, passed inspections, and scaled seamlessly as their products and markets grew.

Whether you’re building your first global PV framework or streamlining an existing one, this webinar will give you the clarity, strategies, and tools to stay compliant without unnecessary complexity.

Watch here

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What you'll learn

• How to align global PV requirements with country-specific activities across Europe while ensuring compliance, traceability, and timely communication (even with limited resources).
• The benefits of centralized PV and how to balance them with local rules in an SME context, including practical ways to address friction points such as literature scope, reporting timelines, and EU-QPPV vs. local RP responsibilities.
• When to apply centralized, hybrid, or decentralized operating models, and how to coordinate effectively between HQ, vendors, and local representatives.
• How SMEs can scale their PV systems to support international growth, remain compliant across multiple countries, and manage local nuances as business expands.
• Real-world SME case studies showing what was implemented, how challenges were resolved, and lessons you can apply immediately.

Speakers

Hear from industry experts who bring hands-on experience in building and optimizing pharmacovigilance systems across global and local settings.

Dr. Almudena Del Castillo

Head of Drug Safety & Vigilance, QbD Group

Dr. Almudena del Castillo is a Medical Doctor and Specialist in Family and Community Medicine, with extensive expertise in pharmacovigilance within the pharmaceutical industry. She has a strong interest in regulatory affairs and drug safety, having held key roles at major pharmaceutical companies, including Pfizer.

She later combined her scientific and business acumen at leading life sciences consultancies, including Pharmalex and PLG, where she served as VP of Sales and Business Development.

Currently, Almudena is Global Division Head of Drug Safety and Vigilance at QbD Group, where she leads the development of globally focused solutions in safety, regulatory compliance, and strategic medical affairs.

Joanna Kurek

Senior Team Lead Vigilance Division QbD Poland

Joanna holds a Master’s degree in Biotechnology and postgraduate qualifications in Industrial Pharmacy. Before moving into Pharmacovigilance, she built broad expertise across the pharmaceutical industry in areas such as Chemistry, Manufacturing and Controls (CMC), Regulatory Affairs, and Strategic Development where she also gained insights into Market Access principles.

Today, Joanna is Senior Team Lead, Vigilance Division at QbD Poland, where she leverages her diverse background to strengthen and optimize Pharmacovigilance systems. Her unique combination of scientific, regulatory, and strategic experience allows her to bridge disciplines and drive the continuous improvement of drug safety practices.

Our support

Whether it’s pharmacovigilance, medical device vigilance, or tailored safety consulting, our experts are here to guide you through every step. Let’s work together to ensure the highest standards of safety and compliance for your products.

Global Safety Solutions

Resources you might find useful

Local Pharmacovigilance Matters: Where Global Strategy Meets On-the-Ground Reality

Global PV success requires more than compliance. Discover how hybrid pharmacovigilance models help pharma companies meet local regulatory demands and build patient trust.

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Scale Smart: Choosing the Right Pharmacovigilance Operating Model for EU Growth

How to choose the right pharmacovigilance operating model (centralized, hybrid, decentralized) to scale smart across Europe while staying compliant.

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Enabling PV Scale: The role of data, systems, and people

Learn how to scale pharmacovigilance across Europe efficiently by managing data, systems, and people while maintaining compliance with Good Pharmacovigilance Practices (GVP).entralized, hybrid, decentralized) to scale smart across Europe while staying compliant.

Read more

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