24 papers · ranked by Valyu relevance
Armando Magrelli, Daniel J. O'Connor, Violeta Stoyanova-Beninska
The regulatory environment is key for protecting public health and has become more complex and sophisticated in recent years, paralleling the advances in scientific discovery and 21st century technological opportunities. The pharmaceutical field and medicines and medical devices development is increasingly global, and…
Di Kevin Gao, Sudip Mittal, Jiming Wu, Hongwei Du + 2 more
'Shahram Rahimi'] Abstract—Artificial Intelligence (AI) has made remarkable progress in the past few years with AI-enabled applications beginning to permeate every aspect of our society. Despite the widespread consensus on the need to regulate AI, there remains a lack of a unified approach to framing, developing, and…
Laura Volpi, Michael D’Agosto, Tom Melvin, Barbara Sickmüller + 1 more
Regulatory Science has gained increasing prominence in the regulatory community, yet its character as a scientific discipline remains insufficiently clarified. While the term is widely used to describe activities that support regulatory decision-making, a unified normative anchoring is lacking. Existing definitions…
Omolayo Tinuke Umaru, Adebowale Sylvester Adeyemi, Olajumoke Aderonmu, Balyodh Singh Bhangu + 4 more
Pharmaceutical regulation plays a central role in protecting public health by governing clinical trials, market authorization, and post-marketing safety monitoring throughout the medicine life cycle. While substantial literature describes established systems, particularly the United States Food and Drug Administration…
María Esther Rodríguez López, Mercedes Gómez del Pulgar, Máximo González-Jurado, Fabiana Maribel Zepeda Arias + 5 more
Background: Nursing regulation is a key component of health system governance; however, its role in structuring the development and deployment of professional competencies remains insufficiently examined, particularly in emerging health systems. Objective: To map and synthesize the evidence on nursing regulation and…
Xihan Xiong, Junliang Luo
Cryptocurrencies have evolved into an important asset class, providing a variety of benefits. However, they also present significant risks, such as market volatility and the potential for misuse in illegal activities. These risks underline the urgent need for a comprehensive regulatory framework to ensure consumer…
Jack Clark, Gillian K. Hadfield
We propose a new model for regulation to achieve AI safety: global regulatory markets. We first sketch the model in general terms and provide an overview of the costs and benefits of this approach. We then demonstrate how the model might work in practice: responding to the risk of adversarial attacks on AI models…
Patrick Chiu, Kathleen Leslie, Gina Jang, Tracey L. Adams + 3 more
'Natalie Thiessen' 'Janice Y. Kung' 'Muhammad Shahzad Aslam'] Health practitioner regulation plays a fundamental role in public protection by overseeing and governing healthcare professionals to ensure they deliver safe health services. It also serves as a strategic lever to strengthen broader health system goals such…
Naima Nasir, Sassy Molyneux, Fred Were, Adeniyi Aderoba + 1 more
Regulatory and other governance arrangements influence the introduction of medical devices into health systems and are essential for ensuring their effective and safe use. Challenges with medical device safety, quality and use are documented globally, with evidence suggesting these are linked to poor governance. Yet…
Lisa Eckstein, Jenny C. Kaldor, Cameron Stewart
In Australia, Human Research Ethics Committees (HRECs) play a ubiquitous role reviewing human subjects research, as do Institutional Review Boards in the US and elsewhere. While HRECs were established as peer review bodies, we argue they should now be characterised a ‘devolved regulator’ within the broader context of…
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This paper explores the transformative potential of Artificial Intelligence (AI) in enabling in silico clinical trials (ISCTs) for vaccine development. ISCTs, which simulate clinical trials using virtual patient cohorts, offer a cost-effective, ethical, and efficient alternative to traditional methods. AI significantly…
Deirdre Ahern
Foresight, Regulatory Experimentation and Regulatory Learning Authors: ['Deirdre Ahern'] With the rapid pace of technological innovation, traditional methods of policy formation and legislating are becoming conspicuously anachronistic. The need for regulatory choices to be made to counter the deadening effect of…
Gillian K. Hadfield, Jack A. Clark
Appropriately regulating artificial intelligence is a pressing policy challenge. Legislatures and regulators lack the specialised technical knowledge required to best translate public demands into legal requirements. Overreliance on industry self-regulation fails to hold producers and users of AI systems accountable to…
Pradyumna Harlapur, Rahul Jagadeesan, Andre Sanches Ribeiro, Claus Kadelka + 1 more
How large-scale regulatory coordination in biological systems emerges from local signed and directed interactions in sparse gene regulatory networks (GRNs) remains an unanswered fundamental question. We introduce the coherence matrix, a topology-based framework that captures the consistency of regulatory influence…
Vicky Chuqiao Yang, Christopher P. Kempes, Sidney Redner, G.B. West + 1 more
'Hyejin Youn'] Regulatory functions are essential in both socioeconomic and biological systems, from corporate managers to regulatory genes in genomes. Regulatory functions come with substantial costs, but are often taken for granted. Here, we empirically examine regulatory costs across diverse systems—biological…
Tarmo Äijö, Richard Bonneau
Via a confluence of genomic technology and computational developments the possibility of network inference methods that automatically learn large comprehensive models of cellular regulation is closer than ever. This perspective will focus on enumerating the elements of computational strategies that, when coupled to…
Ling Chen, John A. Capra
Deep neural networks (DNNs) have achieved state-of-the-art performance in identifying gene regulatory sequences, but they have provided limited insight into the biology of regulatory elements due to the difficulty of interpreting the complex features they learn. Several models of how combinatorial binding of…
Aditya Narayan, Veronica L Irvin, Amanda J Koong, Sujin Song + 1 more
The 21st Century Cures Act (2017) expanded FDA flexibility in applying methodological standards for drug approval. To examine trends before and after implementation, we independently reviewed all novel drugs approved between 2016 and 2024. We constructed a database of all novel FDA approvals from January 1, 2016…
Wenjun Zhao, Alma Plaza-Rodriguez, Pichayathida Luanpaisanon, Elena Xinyi Wang + 4 more
Oscillatory processes such as the cell cycle play critical roles in cell fate determination and disease development. Yet, most current gene regulatory network (GRN) inference methods are based on gene-gene correlations or temporal progression, not adequately accounting for the recurrence in cyclic processes. We…
Authors not listed
In the United States, people of color are disproportionately and unjustly exposed to air pollution. Historically, environmental policy has emphasized aggregate emission reductions; yet major emission reduction scenarios do not sufficiently mitigate relative exposure disparities. Here, we show that without focusing on…
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Next Generation Risk Assessment (NGRA) promotes animal-free, exposure-informed, and hypothesis-driven approaches to chemical safety assessment. In silico tools, such as quantitative structure-activity relationship (QSAR) models, are valuable new approach methodologies (NAMs) for use in NGRA. However, the practical…
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This paper presents an empirical comparison of process control algorithms, with particular emphasis on classical Proportional–Integral–Derivative (PID) control, Model Predictive Control (MPC), and neural network-based methods in the context of complex industrial plants. Since industrial sectors frequently demand…
Ammar Ammar, Chris Evelo, Egon Willighagen
New nanomaterials improve our society. Understanding their effects on biological systems is of importance to improve our understanding of their properties and safety. However, reusability of previously produced data to help developing computational risk assessment tools is still limited, due to the inconsistency in…
Marine Louarn, Anne Siegel, Thierry Fest, Olivier Dameron + 1 more
The Regulatory Circuits project is among the most recent and the most complete attempts to identify cell-type specific regulatory networks in Human. It is one of the largest efforts of public genomics data integration, based on data from the major consortia FANTOM5, ENCODE and Roadmap Epigenomics. This project is a…