--- title: "Scaling Pharmacovigilance in Europe: A Practical Guide for Pharma SMEs and Biotechs" description: "This webinar provides guidance on managing pharmacovigilance (PV) across Europe, focusing on balancing global consistency with country-specific requirements. Participants will learn to meet strict European timelines while working with lean teams and practical strategies to enhance oversight and execution." url: https://qbdgroup.com/en/webinars/scaling-pharmacovigilance-in-europe-a-practical-guide-for-pharma-smes-and-biotechs type: "Webinar" language: en published: 2025-11-13 author: "QbD Group" category: "Pharma" publisher: "QbD Group" citation: "QbD Group, \"Scaling Pharmacovigilance in Europe: A Practical Guide for Pharma SMEs and Biotechs\", https://qbdgroup.com/en/webinars/scaling-pharmacovigilance-in-europe-a-practical-guide-for-pharma-smes-and-biotechs" --- # Scaling Pharmacovigilance in Europe: A Practical Guide for Pharma SMEs and Biotechs > This webinar provides guidance on managing pharmacovigilance (PV) across Europe, focusing on balancing global consistency with country-specific requirements. Participants will learn to meet strict European timelines while working with lean teams and practical strategies to enhance oversight and execution. **Webinar on demand** 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. [Learn more](https://qbdgroup.com/en/webinars/scaling-pharmacovigilance-in-europe-a-practical-guide-for-pharma-smes-and-biotechs#register) On demand 1h Pharma English #### Pharmacovigilance 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 First name\* Last name\* Role\* Department\* Professional Email\* Company name\* Industry \* Country\* Would you like a one-on-one with our team?\* Content Industry -  Yes, I agree to receive personalized newsletters with market insights, invitations for exclusive events and educational webinars from the QbD Group. \* ## 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](https://qbdgroup.com/en/services/pharmacovigilance) ## Resources you might find useful ![Local Pharmacovigilance Matters Where Global Strategy Meets On-the-Ground Reality](https://jrtdedcfhvzaomneervp.supabase.co/storage/v1/object/public/webinar-images/webinars/content/scaling-pharmacovigilance-in-europe-a-practical-guide-for-pharma-smes-and-biotechs/Local_Pharmacovigilance_Matters_Where_Global_Strategy_Meets_On-the-Ground_Reality.jpg) #### 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. Read more ![Scale Smart Choosing the Right Pharmacovigilance Operating Model for EU Growth](https://jrtdedcfhvzaomneervp.supabase.co/storage/v1/object/public/webinar-images/webinars/content/scaling-pharmacovigilance-in-europe-a-practical-guide-for-pharma-smes-and-biotechs/Scale_Smart_Choosing_the_Right_Pharmacovigilance_Operating_Model_for_EU_Growth.jpg) #### 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. Read more ![Enabling Pharmacovigilance Scale The role of data, systems, and people](https://jrtdedcfhvzaomneervp.supabase.co/storage/v1/object/public/webinar-images/webinars/content/scaling-pharmacovigilance-in-europe-a-practical-guide-for-pharma-smes-and-biotechs/Enabling_Pharmacovigilance_Scale_The_role_of_data__systems__and_people.jpg) #### 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 ## We share the latest news Staying on top of the latest in the life science industry can be a daunting task. This newsletter will keep you up-to-date with the latest news, blogs and webinars so you can keep ahead of the curve. 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