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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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Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD

Recent Posts

New revision to EMA Guidance documents released

New revisions of the Preliminary Assessment Review templates, forms and annexes

Second revision to MDCG 2023-3 Guidance document released

New MDCG 2020-16 Revision 3 Guidance Documents Released

MDCG 2022-3 Rev.1 released

Revision of MDCG 2019-13 released

New MDCG 2024-16 form released

New MDCG Guidance document released on the implementation of the Master UDI-DI solution for contact lenses

New MDCG Guidance document released

New Q&A released on the gradual roll-out of EUDAMED

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Events calendar

Industry
Service

June

24.06 - 26.06

Pharma & Biotech
Medical Devices

CPHI China

Shanghai, China

26.06 - 27.06

Pharma & Biotech

PDA Advanced Therapy Medicinal Products Conference (Europe)

Gothenburg, Sweden

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 - 17.09

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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