All Data integrity articles – Page 4
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ArticleEuropean Pharmaceutical Review Issue 3 2023
EPR Issue 3 includes articles the role of titanium dioxide in pharmaceutical formulations, bioprocessing innovations for cell and gene therapies, manufacturing of radiotheranostics and more …
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NewsHow can real-world evidence support regulatory decision making?
Strategies to further accelerate real-world evidence generation to aid EU regulatory decision-making are needed, states a European Medicines Agency (EMA) report.
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Whitepaper
ebook: First-in-human solutions for small and large molecules
Partnering with a drug development solution company that anticipates and mitigates roadblocks can save you time and money. Discover how in this eBook.
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VideoVideo: An introduction to Protak Scientific and Enzyme Indicators for advanced, gaseous bio-decontamination validation
The advanced rapid validation tool for measuring hydrogen peroxide bio-decontamination performance that’s transforming the validation process in pharmaceutical manufacturing and other applications including healthcare and research.
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Whitepaper
Case study: Eliminating contamination with whole genome sequencing
Read this case study to learn how a pharmaceutical company used Accugenix Whole Genome Sequencing for bacterial and fungal ID.
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NewsHow can AI be best harnessed for pharmacovigilance data?
A GSK-funded paper on pharmacovigilance stated that the pharma industry needs to harness the properties of data to allow optimal use of AI, otherwise "we will fail to do all we can for patient safety".
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ArticleDigitalisation of the clinical trial landscape
UCB Pharma's Chief Medical Officer Iris Loew-Friedrich, shares her perspective on digital innovation in clinical trials plus current challenges in clinical data management and how it could evolve in the future.
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Whitepaper
Scientific journal: Reduce CNS drug development timelines by up to 40%
CNS drug development is complex, and partnering with an integrated CRO/CDMO can reduce your timelines by up to 40%. Learn more in The Altascientist.
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Webinar
Strategies for implementing eConsent across the European regulatory landscape
In this webinar, we dive into the intricacies of implementing electronic informed consent (eConsent) in clinical trials within the complex regulatory landscape of European countries.
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Whitepaper
Scientific journal: Planning your first-in-human trial
This issue of The Altascientist provides a thorough review of the first-in-human clinical trial process, including planning and conduct.
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NewsDigital transformation to drive biomanufacturing market
According to a market report, digital transformation is becoming an essential part of biopharma manufacturing.
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Article
Innovating pharma at the edge
Solving the sector-specific challenges of life sciences while enabling innovation requires data integrity, with data collected and analysed at the source in real time, explains Greg Hookings, Industry Director, Stratus Technologies.
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Webinar
Mastering regulatory compliance in inventory management: keys for success
Watch this webinar where Aurélie Chambon will discuss best practices for inventory control and documentation as well as strategies for managing inventory in a compliant manner.
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ArticleEuropean Pharmaceutical Review Issue 2 2023
EPR Issue 2 includes articles on the future of cell and gene therapy, the potential of AAV gene therapies, NMR relaxometry and more…
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Webinar
The hidden costs of microbial misidentifications
Doug Botkin, PhD, examines the challenges and consequences of inaccurate microbial identification methods using real-world case studies and discusses how these challenges can be addressed.
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ArticlePrioritising for a data-driven 2023
As the pharmaceutical industry continues to face unprecedented challenges, the need for greater regulatory compliance and process efficiency remains at the forefront. Here, Frits Stulp predicts how new waves of digital transformation can help support companies deliver the best possible patient outcomes.
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ArticleOvercoming barriers to capturing data in a laboratory
A key issue faced in pharmaceutical laboratories is the integration and standardisation of data from the array of instruments. Here, Samantha Kanza from the University of Southampton outlines some challenges with using laboratory information management systems or other digital tools. How might these be overcome?
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Article
Endotoxin trends: sustainability, automation and beyond
In this Q&A Miriam Guest, Principal Microbiologist at AstraZeneca UK, discusses trends in bacterial endotoxin testing, as well as factors to consider when looking to implement rapid methods.
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Video
Video: Understanding current regulatory thinking on contamination control strategy
Virtual seminar presented by Ziva Abraham, President, and CEO of Microrite designed to improve your understanding on current regulatory thinking on designing an effective contamination control strategy.
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Whitepaper
Case study: Expedite microbial contamination investigations
Find out how rapid microbial monitoring can help mitigate lengthy contamination investigations by identifying the root cause of high plate counts.
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