Regulation and compliance
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Regulation and compliance
European Pharmaceutical Review Issue 4 2025
EPR Issue 4 includes articles on manufacturing, AI/ML, vaccine development, biologics and more.
Why speed and flexibility matter now more than ever
The balance between speed, scale, and compliance has never been more critical. As GLP-1s, biosimilars, and advanced therapies reshape global priorities, pharma leaders face a new question: how can manufacturing infrastructure evolve fast enough to keep pace?
Drug development In-Depth Focus 2025
From groundbreaking cell and gene therapies to cost-effective drug delivery innovations, Europe is emerging as a hub for life-changing therapies. Explore expert insights and innovative solutions shaping the pharmaceutical industry.
Guide to Outsourcing 2025
Doug Botkin, PhD Scientific Portfolio Specialist from Charles River Laboratories, examines how modern microbial ID tools can enhance contamination control strategies and the benefits an outsourcing partner can provide.
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European Pharmaceutical Review Issue 3 2025
EPR Issue 3 includes articles on microbiology, downstream processing, manufacturing, drug formulation and more.
Scaling for the GLP-1 revolution - meeting global injectable demand
In this article, Miguel Angel Ortega Sánchez of ROIS explores how the industry is adapting to new delivery formats, device bottlenecks, and strategic partnership models — and why flexibility, compliance, and tech transfer agility are now critical to success.
Resilient supply, reliable care: safeguarding Europe’s generics in an uncertain world
In this article, Michal Nitka, Senior Vice President, Head of Generics Europe & Global Head OTC, Teva Pharmaceuticals, outlines how policy reform, digital innovation, and manufacturing resilience can secure sustainable access to essential treatments - ensuring generic medicines remain a cornerstone of equitable, reliable care.
AI Act: data governance and compliance strategy implications in Pharma
In this article, Patrice Navarro, Tech Partner (Healthcare & Life Sciences Sector), Clifford Chance, discusses the AI Act and the related compliance considerations for pharmaceutical companies in the EU.
Amid FDA turmoil Sarepta’s gene therapy worries begin to ease
But the impact of George Tidmarsh’s CBER appointment after Vinay Prasad’s abrupt resignation remains to be seen.
Pharma Horizons: leading-edge formulation
This report addresses the key factors shaping pharmaceutical formulation, including regulation, QC and analysis.
A rapid microbiological method case study for advanced therapy medicinal products
In this article, Stacey Ramsey, Senior Manager – Microbial Applications Lab, Charles River Laboratories, discusses the modernisation of rapid microbiological methods (RMMs) and the potential of ATP-bioluminescence when testing cell-based products.
European Pharmaceutical Review Issue 2 2025
EPR Issue 2 includes articles on the impact of tariffs on the pharmaceutical supply chain, advances in bioprocessing, manufacturing and more.
New biosimilar pathways – key takeaways from the EMA’s draft reflection paper
Gain insight on the European Medicines Agency (EMA)’s latest draft reflection paper and its scientific rationale, regulatory implications and potential impact on biosimilar drug development and manufacturing in the EU.
Engineering scalable iPSC-NK therapies
Stefan Braam, Chief Technology Officer, Cellistic, explores the manufacturing and regulatory challenges of scalable, off-the-shelf iPSC-NK cell therapies.
Pharma Horizons: environmental monitoring
This exclusive report addresses the key obstacles and innovations shaping pharmaceutical environmental monitoring, from QC and contamination control, to the impact of advanced technologies and regulatory changes. Discover practical solutions you can implement to drive progress for your organisation.
UK immigration reform – implications for life sciences
This article offers key industry perspectives on the UK government’s recent immigration whitepaper and highlights the challenge of balancing economic growth and attracting skilled talent.
Qualification of non-mutagenic impurities (NMIs)
In this article, Dave Elder reviews the European Medicines Agency (EMA)’s updated reflection paper on the qualification of non-mutagenic impurities (NMIs), which outlines alternative approaches to animal testing.
Regulating decentralised manufacturing in the UK – a legal perspective
Harry Jennings, Partner at VWV, discusses the UK's new framework governing point of care (POC) and modular manufacturing and its implications for manufacturers and marketing authorisation holders in the UK.
Navigating the regulatory challenge of PFAS for pharmaceutical manufacturers
Courtney Soulsby, Sector Development Director, Healthcare at the British Standards Institute, reveals how the industry can prepare for PFAS regulations now to get ahead of the curve.
Beyond instruments: streamlining process technology implementation in biopharmaceutical manufacturing
Colleagues from biopharmaceutical company MSD reveal what it takes to fully realise the benefits of PAT implementation.
The key role of GMP analytical testing for drug products
Ensuring the quality, safety and efficacy of new pharmaceutical products is critical to bring them to market successfully. Here, Adragos Pharma’s Amalia Stroumpou, explains how the key to all three of these factors is rigorous good manufacturing practice (GMP) analytical testing.
AI in pharmaceutical development: hype or panacea?
Dave Elder reflects on the array of applications for AI to facilitate successful drug development, though proof remains elusive.
Pharma Horizons: Artificial Intelligence
EPR’s latest Pharma Horizons report explores the latest advances in artificial intelligence (AI) for drug and clinical development, regulation and more.
European Pharmaceutical Review Issue 1 2025
EPR Issue 1 includes articles on manufacturing, drug delivery, process analytical technology (PAT), RNA therapeutics and more.
Preparing for a new era in the rare disease sector
To mark Rare Disease Day 2025, EPR interviewed Christina Gkousgkouni, Head of Rare Diseases for Central South Europe, Sanofi.
How could tariffs impact the pharmaceutical industry?
Proposed US tariffs on pharmaceutical imports could disrupt global supply chains, drive up production costs, and exacerbate drug shortages. How will the industry respond?
Unlocking intellectual property potential in European pharma
Joshua Harris, Director, Burford Capital, discusses how patent monetisation, including systems like the Unified Patent Court (UPC), enables European pharmaceutical companies to remain competitive and ensure R&D investment and innovation.
Biosimilar medicines: the intersection of access, affordability, and innovation
In this article, Julie Maréchal-Jamil, Director, Biosimilar Policy & Science, Medicines for Europe, explores the strategies needed at European and national levels to secure the benefits of biosimilar medicines in an evolving landscape to deliver a pipeline for these drugs by 2030.