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.
List view / Grid view
Regulation & Legislation
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
During this virtual panel, industry experts will 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.
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.
article
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.
article
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.
whitepaper
Regulatory Authority Inspection Comparison
26 November 2024 | By
A guide on what to expect during a regulatory inspection and the differences in the approach taken by three of the main regulatory authorities and PIC/S.
article
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.
article
European Pharmaceutical Review Issue 5 2024
European Pharmaceutical Review Issue 5 includes articles on bioprocessing, biologics, sustainability, and drug formulation.
news
Encouraging data revealed for schizophrenia long-acting injectables
Key Phase III and real-world data highlight potential advancements in long-acting injectable treatment options for schizophrenia, Teva and Medincell share.
news
Final Chapter <86> text published for early adoption
The Chapter for endotoxin testing using non-animal derived reagents will help quality professionals ensure the safety of sterile pharmaceutical products.
news
Sustainability continues to steer pharmaceutical packaging market
Europe’s emphasis on sustainability combined with its established infrastructure to support market growth, means the region is leading the pharmaceutical containers market, with potential to hold this position into the next decade, research anticipates.
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.
article
Developing donanemab – balancing cost versus benefit
This article summarises recent regulatory developments surrounding the Alzheimer’s treatment donanemab and considers the future therapeutic market for this disease.
