Recursos

Mantente al día en Life Sciences con perspectivas de expertos, actualizaciones regulatorias y orientación práctica.

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526 recursos

BPL y BPM: Estrategias para blindar el cumplimiento y evitar hallazgos críticos en auditoría

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BPL y BPM: Estrategias para blindar el cumplimiento y evitar hallazgos críticos en auditoría

Quality Assurance26 jun 2026

Descubre el enfoque BxP para alinear BPL y BPM, cerrar brechas técnicas entre laboratorio y planta, y blindar el cumplimiento ante hallazgos críticos en auditorías regulatorias.

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Scaling Pharmacovigilance in Europe

Scaling Pharmacovigilance in Europe

Pharmacovigilance21 may 2026 1 min

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.

What to Look for When Selecting a CRO for IVD Performance Studies

What to Look for When Selecting a CRO for IVD Performance Studies

Clinical20 may 2026 4 min

Not every CRO is equipped for IVD performance studies. Learn the nine capabilities that matter most for compliant, defensible evidence generation.

Three Sponsorship Models for Combined IVD-Drug Studies: How to Choose the Right One for Your Program

Three Sponsorship Models for Combined IVD-Drug Studies: How to Choose the Right One for Your Program

Clinical20 may 2026 5 min

Explore the three main sponsorship models for combined IVD-drug studies and learn how governance structures impact compliance, timelines, and data ownership.

Delegation vs. Transfer of Sponsor Responsibilities: The Line Every IVD Performance Study Sponsor Needs to Draw

Delegation vs. Transfer of Sponsor Responsibilities: The Line Every IVD Performance Study Sponsor Needs to Draw

Clinical20 may 2026 3 min

Understand the difference between delegating operational tasks and transferring Sponsor responsibilities in IVD performance studies under IVDR and FDA frameworks.

Who Is the Sponsor of Your IVD Performance Study and Why It Matters More Than You Think

Who Is the Sponsor of Your IVD Performance Study and Why It Matters More Than You Think

Clinical20 may 2026 4 min

Learn who carries Sponsor responsibility in IVD performance studies and why this role shapes compliance, data ownership, and regulatory success.

Why Most AI Pilots Fail in Regulated Environments and How to Fix It

Why Most AI Pilots Fail in Regulated Environments and How to Fix It

Software Solutions & Services17 may 2026 5 min

Discover why AI pilots in pharma often fail before production and how governance, workflows, and data foundations determine success.

How MedTech's AI Playbook Can Accelerate Compliant AI Adoption in Pharma

How MedTech's AI Playbook Can Accelerate Compliant AI Adoption in Pharma

Software Solutions & Services13 may 2026 7 min

Discover how MedTech's validated AI approach can help pharma accelerate compliant AI adoption across R&D, clinical trials, and GMP operations.

AI in Life Sciences: From Hype to Compliant Reality

AI in Life Sciences: From Hype to Compliant Reality

Software Solutions & Services13 may 2026 3 min

Discover why governance, validation, and trust, not model performance, are the real challenges for AI adoption in life sciences.

Why AI Is Too Generic for Regulatory Conversations in Life Sciences

Why AI Is Too Generic for Regulatory Conversations in Life Sciences

Software Solutions & Services13 may 2026 4 min

Discover why AI governance in life sciences depends on intended use, risk context, and control frameworks rather than the AI label itself.

Structural Heart and Coronary Trials in Europe: What Can Go Wrong

Structural Heart and Coronary Trials in Europe: What Can Go Wrong

Clinical13 may 2026 5 min

Discover the most common operational and regulatory pitfalls in structural heart and coronary trials across Europe, and how to mitigate them early.

Running Your First Structural Heart Trial in Europe: What to Expect Before You Start

Running Your First Structural Heart Trial in Europe: What to Expect Before You Start

Clinical13 may 2026 3 min

Discover what non-EU sponsors should expect when launching a first structural heart or coronary device trial in Europe under the MDR framework.

Scaling a Global Pharmacovigilance Model for International Growth

Scaling a Global Pharmacovigilance Model for International Growth

Pharmacovigilance6 may 2026 2 min

Discover how QbD Group helped a Spanish pharmaceutical company develop a scalable pharmacovigilance model supporting international growth and regulatory compliance.

Building a Global Pharmacovigilance Framework for Seamless EU Entry and Worldwide Expansion

Building a Global Pharmacovigilance Framework for Seamless EU Entry and Worldwide Expansion

Pharmacovigilance6 may 2026 2 min

Discover how QbD Group helped a Chinese biopharmaceutical company build a scalable global pharmacovigilance framework for EU entry and worldwide expansion.

Cómo implementar la Evaluación de Riesgos Ambientales (ERA): Desafíos clave en la industria farmacéutica

Cómo implementar la Evaluación de Riesgos Ambientales (ERA): Desafíos clave en la industria farmacéutica

ToxicologyRegulatory Affairs6 may 2026 5 min

Descubre los desafíos prácticos de las Evaluaciones de Riesgos Ambientales (ERA) en la industria farmacéutica, desde el aporte toxicológico hasta la coherencia de los datos y la gestión del ciclo de vida.

Governance in Combined Studies: Getting Roles Right Before the Clock Starts

Governance in Combined Studies: Getting Roles Right Before the Clock Starts

Regulatory Affairs6 may 2026 5 min

Discover why governance and role clarity are critical in combined drug-diagnostic studies under the CTR and IVDR.

Why Pharma and IVD Partners Must Collaborate Earlier Than You Think

Why Pharma and IVD Partners Must Collaborate Earlier Than You Think

Regulatory Affairs6 may 2026 4 min

Discover why early collaboration between pharma sponsors and IVD partners is critical for successful companion diagnostic development under the IVDR.

The Harmonisation Gap: Managing EU Performance Study Submissions

The Harmonisation Gap: Managing EU Performance Study Submissions

Regulatory Affairs6 may 2026 4 min

Discover why IVDR performance study submissions remain fragmented across Europe and how regulatory differences impact timelines and study strategy.

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