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

Recent Posts

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

MDCG 2023-3 Rev 1 released

New MDCG Guidance Documents Released

New MDCG Guidance Documents Released: Key Updates and Insights

New MDCG & Stakeholders Survey on MDR/IVDR Certifications and Applications Released by Notified Bodies

EU Parliament Passes Groundbreaking Proposal

New MDCG Guidance on Safety Reporting for Performance Studies of In Vitro Diagnostic Medical Devices under EU Regulation 2017/746 Released

New MDCG Guidance on Investigator’s Brochure Content for Clinical Investigations of Medical Devices

Events calendar

February

03.02 - 06.02

Medlab Middle East 2025

11.02 - 02.12

BIVDA 2025 Regulatory Affairs Summit

24.02 - 25.02

RMD Annual EAAR conference on new MDR

27.02 - 28.02

International Conference on Stem Cells & Regenerative Medicine

March

01.03 - 02.03

International Conference on Gene & Cell Therapies

11.03 - 12.03

RAPS Global Regulatory Strategy Conference 2025

18.03 - 19.03

Advanced Therapies Congress

22.03 - 24.03

CALCP

25.03 - 29.03

IDS 2025

April

08.04 - 10.04

World Clinical Biomarker & CDx Europe Summit

11.04 - 15.04

ESCMID

30.04 - 01.05

AMDM Annual Regulatory Meeting

May

08.05 - 08.05

Knowledge for Growth

08.05 - 09.05

EMWA Symposium

12.05 - 14.05

ISPE Europe Annual Conference

13.05 - 16.05

RAPS Euro Convergence 2025

13.05 - 16.05

Raps EuroConvergence 2025

20.05 - 23.05

EuroPCR: World-Leading Course in interventional cardiovascular medicine

22.05 - 22.05

Symposium on Diagnostic and surveillance of infectious diseases (Sciensano)

June

03.06 - 04.06

OCT Medical Devices USA

11.06 - 13.06

EFORT Annual Congress

16.06 - 19.06

Bio-International

24.06 - 26.06

CPHI China

26.06 - 27.06

PDA Advanced Therapy Medicinal Products Conference (Europe)

September

07.09 - 11.09

LSI Europe

17.09 - 17.09

Farmaforum

23.09 - 23.09

BioWin day

29.09 - 01.10

TOPRA annual Symposium

October