FDA issues first recommendations on AI for drug development
The new US Food and Drug Administration (FDA) guidance will enhance credibility of AI models in drug and biological product regulatory submissions.
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The new US Food and Drug Administration (FDA) guidance will enhance credibility of AI models in drug and biological product regulatory submissions.
Dr Vladimir Makarov, AI Community lead, The Pistoia Alliance, explains that despite the willingness of the life sciences R&D industry to adopt artificial intelligence (AI), data integrity is a key area that must be addressed to ensure successful integration of this fast-evolving technology.
Experts at IP firm Finnegan discuss if the pharmaceutical industry is ready for the innovation and technologies that digitalisation and automation will bring, and whether these advances are a threat or ally to intellectual property rights in the sector.
In this podcast, Giovanni Nisato, Project Manager at the Pistoia Alliance discusses data integrity and the progress towards implementation of FAIR data principles in the pharmaceutical industry.
It is a well-established expectation that regulatory processes will become increasingly data focused, which places a new urgency on data quality governance in the pharmaceutical industry. In this Q&A Steve Gens and Preeya Beczek present a pragmatic view of what is involved.
Between 9 - 12 April 2024, the world’s leading trade fair analytica will once again open its doors in Munich to the international laboratory industry. At analytica, industry experts, exhibitors and visitors gather to explore the latest developments in laboratory technology, analysis and biotechnology. The fair, covering the entire spectrum…
EPR's inaugural Pharma Horizons report explores the latest advances in artificial intelligence (AI) and machine learning (ML) for drug development, pharmaceutical manufacturing and quality control.
EPR speaks to Henry Levy, President, Life Sciences at Clarivate to gain a sense of how artificial intelligence (AI), and particularly Generative AI (GenAI), is transforming the pharmaceutical industry.
The integration of artificial intelligence (AI) in pharmaceutical manufacturing is set to open a brand-new chapter in this industry's development, as well as unprecedented opportunities for strengthening quality control and improving decision-making. In this article, Dr Gonesh Chandra Saha, Head of the Department of Computer Science & Information Technology at…
A coordinated workplan, which runs to 2028 will help European regulators embrace opportunities for artificial intelligence.
Krishna Venkatesh, Global Head Sterile Operations at Dr Reddy's Laboratories discusses how and why the pharma industry is embracing automation.
In this exclusive interview from CPHI 2023, Mohamed Noor, Digitalization Manager at the National Institute for Bioprocessing Research and Training (NIBRT), explores the trends, challenges and opportunities that digitalisation and process analytical technology (PAT) have within the biopharmaceutical industry.
In this exclusive interview, Dr Uwe Hanenberg, Head of Product Development at Recipharm discusses the current landscape and future innovations in oral solid dosage (OSD) formulation.
On 18 October 2023, Schneider Electric’s unique event brings together six leading speakers who will explore the future of biotechnology and personalised medicine using AI & digital transformation in life sciences.
Digitalisation is a driving factor for the global process analytical technology (PAT) market, according to a report.