Life Sciences Webinars

AI in Life Sciences: Session 2, Your Questions Answered

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.

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

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.

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

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.

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

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.

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