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.

11 articles

PharmacovigilanceMay 21, 2026 1 min

Scaling Pharmacovigilance in Europe

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.

PharmacovigilanceMar 27, 2026 6 min

Scaling Pharmacovigilance Across Europe: Managing Local Requirements Without Losing Control

Expanding across Europe introduces complex pharmacovigilance requirements. Learn how EU PV systems can scale while integrating national roles and regulatory obligations.

PharmacovigilanceMar 25, 2026 5 min

AI in Pharmacovigilance: Efficiency Tool or Strategic Game-Changer?

AI is transforming pharmacovigilance processes from case processing and literature monitoring to signal detection. Discover how AI and NLP can enhance efficiency, compliance, and regulatory intelligence.

Regulatory AffairsMar 4, 2026 3 min

ICH E2D(R1) – New Expectations for ODCS, PSPs, MRPs & Digital Platforms

ICH E2D(R1) introduces new expectations for ODCS, PSPs, MRPs and digital platforms. Learn what MAHs must implement by 18 March 2026 to ensure pharmacovigilance compliance.

PharmacovigilanceFeb 13, 2026 4 min

Scaling PV Governance in Europe: Maintaining Oversight as Organizations Grow

As European SMEs and biotechs expand, PV governance must scale to maintain EU-QPPV oversight and inspection readiness. Learn how to build a scalable pharmacovigilance system.

PharmacovigilanceOct 28, 2025 2 min

Enabling Pharmacovigilance 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).

PharmacovigilanceOct 8, 2025 6 min

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.

PharmacovigilanceOct 6, 2025 2 min

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.

Regulatory AffairsSep 11, 2025 1 min

EU Pharmacovigilance: Implementing Regulation (EU) 2025/1466

The European Commission has amended Regulation (EU) No 520/2012 on pharmacovigilance. The update strengthens oversight of outsourced PV activities, clarifies EudraVigilance monitoring, and aligns processes with international data standards (IDMP, MedDRA, Standard Terms).

PharmacovigilanceMay 21, 2025 2 min

How to Transform Pharmacovigilance into a Growth Strategy

Learn how to optimize pharmacovigilance systems and outsource strategically to turn compliance into business growth.

PharmacovigilanceSep 18, 2024 5 min

Technovigilance in Action: Safeguarding Health with Post-Market Surveillance of Medical Devices

Learn how technovigilance ensures medical device safety through post-market surveillance, tackling risks, compliance, and best practices.

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