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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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Expanded eIFU Eligibility under EU Regulation 2025/1234

FDA Deadline Update - Risk of nitrosamine drug substance-related impurity (NDSRI)

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

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Events calendar

Industry
Service

July

27.07 - 31.07

In Vitro Diagnostics

ADLM

Chicago (IL), USA

August

29.08 - 01.09

Medical Devices

ESC Congress

Madrid, Spain

September

07.09 - 11.09

Medical Devices

LSI Europe

London, UK

17.09 - 18.09

Pharma & Biotech

Farmaforum

Madrid, Spain

23.09 - 23.09

Pharma & Biotech

BioWin day

Namur, Belgium

25.09 - 25.09

Pharma & Biotech
Medical Devices
In Vitro Diagnostics

QbD Group x Gevers Roadshow: Liège

Liège - LégiaPark

29.09 - 01.10

Medical Devices
Pharma & Biotech

TOPRA annual Symposium

Berlin, Germany

October

07.10 - 08.10

Medical Devices

World Drug Safety Congress

Amsterdam, The Netherlands

07.10 - 10.10

Pharma & Biotech
Medical Devices

RAPS US Convergence

Pittsburgh, UK

16.10 - 16.10

Medical Devices

Healixia Clinical Conference

Brussels, Belgium

19.10 - 20.10

In Vitro Diagnostics

Annual EU In Vitro Diagnostics Clinical & Regulatory Conference (Q1)

Brussels, Belgium

23.10 - 23.10

In Vitro Diagnostics
Medical Devices
Pharma & Biotech

QbD Group x Gevers Roadshow: Liège

Diepenbeek - BioVille

23.10 - 24.10

Medical Devices

Team-PRRC Annual Summit

Rome, Italy

25.10 - 28.10

Medical Devices

TCT 2025

San Francisco (CA), USA

28.10 - 30.10

Pharma & Biotech
Medical Devices

CPHI Europe

Frankfurt, Germany

November

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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