Life Sciences Webinars

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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