news
Innovative biologic prefilled syringe approved in EU
The new treatment option provides a convenient alternative to currently available vials of the bispecific antibody for EU patients with common vision conditions.
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Regs & Legs
news
Legislative milestone for UK clinical trials
The amended regulatory framework will foster clinical trial design innovation and provide UK life sciences with faster trial approvals.
whitepaper
NSF’s quality management maturity (QMM) assessment model
10 December 2024 | By
NSF’s quality management maturity (QMM) assessment model: future-proofing quality and supporting supply chain robustness
webinar
Navigating pharmaceutical environmental monitoring in a changing industry
9 December 2024 | By European Pharmaceutical Review, sponsored by Charles River Laboratories
During this virtual panel, industry experts explore the latest advances in environmental monitoring, discuss key challenges within the sector and approaches that can prevent and mitigate these issues.
news
Restoring regulatory excellence “central” to UK life science competitiveness
The Association of the British Pharmaceutical Industry (ABPI) asserts that the recommendations will help generate confidence and predictability in medicine regulation in the UK.
whitepaper
Understanding and Applying Updated FDA Guidance
Understanding and Applying the Updated FDA Guidance: Inspection of Injectable Products for Visible Particulates.
news
New mass spectrometry Chapter could “revolutionise” biopharma quality assurance
Launch of the USP general method chapter signals a breakthrough in pharmaceutical drug impurity control, according to biopharma experts.
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Pharma Horizons: Sustainability
European Pharmaceutical Review’s latest Pharma Horizons report provides insight on key sustainability developments in the pharmaceutical industry and covers topics including regulation, manufacturing and clinical development.
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The EU AI Act: will regulation drive life science innovation away from Europe?
Mike King, Senior Director, Product & Strategy (Quality, Regulatory, Safety & Detect), Digital Products & Solutions at IQVIA and Alex Denoon, Partner at Bristows Law Firm, explore the challenges of implementing the EU AI Act and the impact of GDPR requirements in life sciences.
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Easing the mental health burden with psychedelic therapies – what’s next for the regulatory and clinical landscape?
In this article, Steffanie Wilson, Vice President and Neuroscience Therapeutic Area Lead, Emmes Group, discusses the future of psychedelic research and highlights the impact of the FDA’s decision on Lykos Therapeutics’ NDA for its MDMA therapy to treat PTSD.
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European Pharmaceutical Review Issue 5 2024
European Pharmaceutical Review Issue 5 includes articles on bioprocessing, biologics, sustainability, and drug formulation.
whitepaper
Whitepaper: What to expect from a regulatory inspection, an NSF expert guide
Regulatory inspections can be challenging, but proper preparation turns them into opportunities for improvement and compliance demonstration.
news
First-of-a-kind EU approval granted for eosinophilic esophagitis medicine
With its novel approach for addressing a fundamental cause of eosinophilic esophagitis, approval of the biologic marks a potential new standard of care for paediatric patients.
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Life sciences response to 2024 Autumn Budget
Research and innovation is highlighted in the UK’s Autumn Budget as a priority ‘crucial national asset’ to aid long-term economic growth.
whitepaper
Whitepaper: Optimise organisational culture & quality maturity
31 October 2024 | By NSF
Whitepaper - Optimising organisational culture and quality maturity is crucial in promoting consistent, reliable business processes and to minimise supply disruptions.
