Regulatory Updates

The QbD Group regulatory updates blog provides professionals in the life sciences with timely and insightful information on the latest regulatory trends, guidelines, and compliance requirements. Covering topics from pharmaceutical manufacturing standards to medical device approvals, the blog aims to support readers in navigating complex regulatory landscapes, ensuring product safety, and accelerating time to market. Whether you're involved in quality assurance, regulatory affairs, or product development, this blog offers valuable resources to keep you informed and compliant.

Regulatory Updates

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4 key guidance documents released under the EU MDR and IVDR frameworks

Launch of the first phase of the COMBINE Project 1 pilot - "all-in-one” coordinated assessment

Nitrosamines Update EMA/409815/2020 Rev.22

New Manufacturer Incident Report template and IMDRF terminologies for categorized Adverse Event Reporting released

New UK Clinical Trials Regulations: Key Updates and What They Mean

New revision of Team-NB Best Practice Guidance released

New revision of Team-NB Position Paper on European AI Act

New Team-NB Position Paper Released on IVDR certification process

New Revision to MDCG 2020-16 Guidenance Document Released

Fifth revision to MDCG 2019-6 Guidance document released

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Events calendar

Industry
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November

17.11 - 20.11

Medical Devices

Medica 2025

Düsseldorf, Germany

17.11 - 20.11

Pharma & Biotech
Medical Devices

Medica

Dusseldorf, Germany

December

11.12 - 11.12

Medical Devices
Pharma & Biotech

Dutch Life Science conference

Leiden, The Netherlands
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Upcoming webinars

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Scaling Pharmacovigilance in Europe: A Practical Guide for Pharma SMEs and Biotechs

This live webinar will provide clear, experience-based guidance on how to manage pharmacovigilance (PV) across Europe without overextending your resources. You’ll learn how to balance global consistency with country-specific requirements, meet strict European timelines with lean teams, and apply practical, proven strategies that strengthen both central oversight and local execution.
Vigilance
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