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

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

Call for expression of interest in coordinated assessment of clinical investigations/performance studies

PMS Statutory Instrument + MHRA Guidance released (Great Britain)

New MDCG Guidance documents released

Expert Panel Advice on SARS-CoV-2

Events calendar

June

24.06 - 26.06

CPHI China

26.06 - 27.06

PDA Advanced Therapy Medicinal Products Conference (Europe)

July

27.07 - 31.07

ADLM

August

29.08 - 01.09

ESC Congress

September

07.09 - 11.09

LSI Europe

17.09 - 17.09

Farmaforum

23.09 - 23.09

BioWin day

25.09 - 25.09

QbD Group x Gevers Roadshow: Liège

29.09 - 01.10

TOPRA annual Symposium

October

07.10 - 08.10

World Drug Safety Congress

07.10 - 10.10

RAPS US Convergence

16.10 - 16.10

Healixia Clinical Conference

19.10 - 20.10

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

23.10 - 23.10

QbD Group x Gevers Roadshow: Liège

23.10 - 24.10

Team-PRRC Annual Summit

25.10 - 28.10

TCT 2025

28.10 - 30.10

CPHI Europe

November

17.11 - 20.11

Medica

December

11.12 - 11.12

Dutch Life Science conference