Knowledge Center | QbD Group

AI in Life Sciences: Session 2, Your Questions Answered

Software Solutions & ServicesMay 13, 2026

Adopting AI in life sciences holds enormous potential, but navigating GxP requirements adds real complexity. In this joint session, QbD Group and delaware walk you through how to deploy AI that is trustworthy, validated, and inspection-ready, covering data governance, explainability, and lifecycle management. Building on the first session, this edition dedicates more time to answering your questions, addressing the topics raised by the audience in Session 1, and opening the floor for live debate and discussion.

Upcoming Webinar

EU GMP Annex 1 Implementation: From Regulatory Expectations to Practical Remediation

Qualification & ValidationQuality AssuranceApr 30, 2026

This webinar translates the revised EU GMP Annex 1 requirements into structured, practical actions across sterile manufacturing environments. Learn how to assess implementation challenges, prioritize remediation efforts and strengthen sustainable compliance.

Upcoming Webinar

Entering the European MedTech Market: Why One Approval Doesn't Fit All

Regulatory AffairsApr 29, 2026

Building on QbD Group's Landing in Europe MedTech whitepaper, this webinar explains why EU market entry requires a fundamentally different approach than you might expect. We'll explore where home-market regulatory logic breaks down in Europe — with a specific focus on clinical evidence expectations, Notified Body interactions, and lifecycle obligations.

Upcoming Webinar

Navigating Grey Zones & Growing Pains: Developments in the Regulatory CDx Space

Regulatory AffairsApr 8, 2026

Join Kirsten van Garsse (QbD Group) and Jules Petit (GenDx) as they discuss key regulatory developments and trends in the Companion Diagnostics space, exploring the grey zones and growing pains of CDx co-development between Pharma and IVD manufacturers.

White Paper

Sponsor Responsibilities in IVD Clinical Performance Studies

Clinical, Regulatory AffairsMar 30, 2026 1 min

Understand sponsor responsibilities in IVD clinical performance studies under IVDR, FDA IDE and ISO 20916, including delegation, CRO roles and combined study models.

Regulatory Update

ISO 14155:2026 – What You Need to Know

ClinicalMar 30, 2026 4 min

ISO 14155:2026, the fourth edition of the international Good Clinical Practice standard for medical device clinical investigations, has been published. It replaces ISO 14155:2020 and sets new requirements for risk management, Clinical Events Committees, Data Monitoring Committees, study design and adverse event reporting.

Blog

Scaling Pharmacovigilance Across Europe: Managing Local Requirements Without Losing Control

PharmacovigilanceMar 27, 2026 6 min

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

Blog

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

PharmacovigilanceMar 25, 2026 5 min

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.

Blog

From R&D to Market: Why the Product Lifecycle Is the Strategic Framework for MedTech

Regulatory AffairsMar 25, 2026 4 min

Successful MedTech companies treat product development as a lifecycle strategy. Learn why regulatory planning, IP strategy and development must evolve together.

Blog

SaMD Under EU MDR: What Software Developers Need to Know

Regulatory AffairsMar 24, 2026 3 min

Developing Software as a Medical Device under EU MDR requires clear intended use, risk classification under Rule 11, and compliance with IEC 62304. Learn what SaMD developers need to know.

Blog

IP Strategy for MedTech Startups: What Early-Stage Companies Often Miss

Regulatory AffairsMar 23, 2026 4 min

IP strategy should start early in MedTech development. Discover how patent strategy, regulatory classification, and product development influence IP protection for emerging MedTech companies.

Blog

EU MDR Compliance for MedTech Startups: What It Really Takes

Regulatory AffairsMar 22, 2026 5 min

EU MDR compliance can be challenging for emerging MedTech companies. Learn what MDR actually requires, from qualification and QMS to technical documentation and post-market obligations.

Blog

3 Things MedTech Startups Get Wrong About IP & Regulatory Strategy

Regulatory AffairsMar 21, 2026 4 min

Many MedTech startups treat IP and regulatory strategy as separate disciplines. Discover the three most common mistakes and how aligning both early strengthens market access and product value.

On Demand Webinar

AI in Life Sciences

Software Solutions & ServicesMar 19, 2026

Leveraging AI in life sciences is powerful, but also complex under GxP. In this joint webinar, QbD Group and delaware show how to implement AI in a trustworthy, validated, and inspection-ready way, with the right approach to data, explainability, and lifecycle management.

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On Demand Webinar

From Strategy to First-in-Human: A Practical Roadmap for Biotech Development

Regulatory AffairsMar 18, 2026

Early-stage biotech teams often struggle to translate scientific innovation into first-in-human readiness. This webinar provides practical guidance to help teams build a clear, scalable development pathway that aligns regulatory strategy, CMC, quality, and clinical planning. Reducing risk, avoiding delays, and staying inspection-ready without overbuilding internal structures.

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White Paper

Annex 1 Compliance Signals from FDA Warning Letters

Qualification & ValidationMar 13, 2026 1 min

What do 230 FDA warning letters reveal about recurring sterile manufacturing deficiencies? This white paper analyses inspection findings from 2023–2025 and maps them to EU GMP Annex 1 expectations, revealing where manufacturers most frequently fall short of sustainable compliance.

On Demand Webinar

Cleaning Validation Based on PDEs

Qualification & ValidationMar 11, 2026

Join our webinar and discover how to apply PDEs (Permitted Daily Exposures) to minimize critical risks and ensure regulatory compliance, combining science, statistics, and advanced digital tools. Learn from experts how to transform cleaning validation into a safer, more efficient, and predictable process.

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Blog

Scientific Advice for Startups: Turning the Right Questions into Regulatory Clarity

Regulatory AffairsMar 4, 2026 4 min

Scientific Advice is one of the few moments in early development where a biotech can test its assumptions with regulators. Learn how to structure questions, integrate CMC and clinical strategy, and leverage EMA SME support for maximum impact.