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

Why-self-inspections-or-internal-audits-are-essential-for-your-QMS-1536x864

Upcoming webinars

PMS & PMCF Compliance for Medical Devices Under EU MDR

Join our expert-led webinar series and discover how to turn PMS & PMCF compliance into clinical and strategic advantage — with exclusive insights from a notified body.

Clinical

Regulatory Updates

Regulatory Updates

Select your

or

EU Pharmacovigilance: Implementing Regulation (EU) 2025/1466

ICH Draft Q3E Guideline on Extractables & Leachables Now Open for Consultation

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

Events calendar

September

17.09 - 18.09

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 Frankfurt

November

17.11 - 20.11

Medica 2025

17.11 - 20.11

Medica

December

11.12 - 11.12

Dutch Life Science conference

Upcoming webinars

PMS & PMCF Compliance for Medical Devices Under EU MDR