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ICMRA set out recommendations for AI regulation in medicine
The ICRMA has set out recommendations to help regulators tackle the challenges posed by artificial intelligence (AI) in medicine.
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Big Data
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Assessing pharma’s readiness for digital product information management
With new EU IDMP guidance now published, how can pharma firms reap the benefits of a digital product information management future? Here, Iperion’s Adnan Jamil explains.
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AI and big data will continue to disrupt pharma sector, says survey
A GlobalData report has revealed the extent to which companies will be using AI and big data in drug discovery and development processes.
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Strengthening the pharma industry’s cyber security defence
Cyber hackers target businesses of all shapes and sizes, but the pharmaceutical industry remains a prime target, especially as these companies undergo digital transformation and move high value data online. But how can the industry protect itself from the threat of cyber attack? Jack Garnsey, Product Manager at VIPRE SafeSend…
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Revised general chapter on chemometric methods available for comment
The revised general chapter 5.21 has been published in Pharmeuropa 33.3, the European Pharmacopoeia online forum, for public comment.
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Big pharma collaborates on free resource linking genetic variants to human disease
The collaborative work has produced the largest browsable resource linking rare protein-coding genetic variants to human health and disease that will accelerate targeted drug development.
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Using software to improve data management and output in pharma development
The COVID-19 pandemic has exposed various issues with the software and data processes employed in the pharmaceutical industry and spurred rapid digital transformation at a rate never before seen in the sector. In this article, Jordan Stobaugh, Principal Research Scientist at AbbVie, discusses how software can improve data management and…
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Implementing the FAIR data principles is now a critical endeavour
With companies acknowledging the value of their data, it becomes increasingly important that data integrity be assured – and data stewardship implemented. In this article, Ian Harrow and Thomas Liener, Consultant Project Managers at The Pistoia Alliance explain the importance of the FAIR (Findable, Accessible, Interoperable, Reusable) data principles, factors…
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The role of digital transformation in achieving Pharma 4.0
Pharma 4.0 represents the next step in the evolution of pharmaceutical manufacturing, and is heralded as providing manufacturers with better efficiencies, higher output and quality, as well as flexible production. Here, Dr Saly Romero-Torres highlights some of the key trends in digital transformation and explains why a strong informatics infrastructure…
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Guide to Data Integrity
Welcome to European Pharmaceutical Review’s Guide to Data Integrity. In this edition, Ian Harrow and Thomas Liener, Consultant Project Managers at The Pistoia Alliance, explain the importance of the FAIR data principles; and Charles River Laboratories and Thermo Fisher Scientific showcase their unique data integrity services and discuss how they…
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Manufacturing, Packaging & Logistics In-Depth Focus 2021
In this in-depth focus, find out about the key points to consider when implementing new software in the pharma development space and the current positions of the EMA and FDA with regards to nitrosamine contaminants.
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Evolving your adverse event monitoring strategy for the post-COVID data influx
Marketing authorisation holders are increasingly challenged to identify all potential adverse events (AEs) and proactively address them with each new product that comes to market. In this article, Alison Sloane, General Manager of Vigilance Detect at IQVIA, discusses how adopting technology can not only streamline pharmacovigilance processes, but also address…
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ICMRA and WHO state clinical trial reports should be published without redaction
The International Coalition of Medicines Regulatory Authorities (ICMRA) and WHO are calling on pharma to provide voluntary unrestricted access to trial results data.
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Bringing clinical trials into the new age with blockchain
Rama Rao, CEO of Bloqcube, discusses the benefits of blockchain-based systems for clinical trials and how their implementation could revolutionise drug development.
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New group to tackle data governance and guide digital transformation in pharma
The Pistoia Alliance's Data Governance Community of Interest will develop best practices and advance digital transformation in the pharma/life sciences industry.
