Literature DB >> 32494046

Cloud-based data systems in drug regulation: an industry perspective.

Andrew S Robertson, Hilary Malone, Fabio Bisordi, Helen Fitton, Carlos Garner, Stacy Holdsworth, Peter Honig, Mathias Hukkelhoven, Robert Kowalski, Sandra Milligan, Liza O'Dowd, Khyati Roberts, Michelle Rohrer, Jerry Stewart, Mark Taisey, Roopal Thakkar, Karin Van Baelen, Max Wegner.   

Abstract

Year:  2020        PMID： 32494046     DOI： 10.1038/d41573-019-00193-7

Source DB:  PubMed          Journal:  Nat Rev Drug Discov        ISSN： 1474-1776            Impact factor:   84.694


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  6 in total

1.  Digital Innovation in Medicinal Product Regulatory Submission, Review, and Approvals to Create a Dynamic Regulatory Ecosystem-Are We Ready for a Revolution?

Authors:  Judith C Macdonald; David C Isom; Daniel D Evans; Katy J Page
Journal:  Front Med (Lausanne)       Date:  2021-05-21

2.  New Approaches to Regulatory Innovation Emerging During the Crucible of COVID-19 : In Responding to a Global Health Crisis, Industry is Discovering New, Efficient Ways of Meeting Objectives.

Authors:  Max Wegner
Journal:  Ther Innov Regul Sci       Date:  2020-11-25       Impact factor: 1.778

Review 3.  Regulatory Agilities in the Time of COVID-19: Overview, Trends, and Opportunities.

Authors:  Winona Rei Bolislis; Maria Lucia de Lucia; Felipe Dolz; Runyi Mo; Makoto Nagaoka; Heraclio Rodriguez; May Li Woon; Wei Yu; Thomas C Kühler
Journal:  Clin Ther       Date:  2020-11-30       Impact factor: 3.393

Review 4.  Translational precision medicine: an industry perspective.

Authors:  Dominik Hartl; Valeria de Luca; Anna Kostikova; Jason Laramie; Scott Kennedy; Enrico Ferrero; Richard Siegel; Martin Fink; Sohail Ahmed; John Millholland; Alexander Schuhmacher; Markus Hinder; Luca Piali; Adrian Roth
Journal:  J Transl Med       Date:  2021-06-05       Impact factor: 5.531

5.  Dynamic Dossier in the Cloud: A Sociotechnical Architecture for a Real-Time and Metrics-Based Data Tracking System with Gene and Cell Therapies as a Case Study.

Authors:  Kevin Nam; Kay Larholt; Gigi Hirsch; Paul Beninger; David Fritsche; Diane Shoda; John Ferguson; Florence T Bourgeois; Donna Palmer; Karen Katz; Matt W Courtney
Journal:  Ther Innov Regul Sci       Date:  2020-10-28       Impact factor: 1.778

6.  COVID-19: A Catalyst to Accelerate Global Regulatory Transformation.

Authors:  Jerry Stewart; Peter Honig; Lina AlJuburi; Deborah Autor; Susan Berger; Patrick Brady; Helen Fitton; Carlos Garner; Michael Garvin; Mathias Hukkelhoven; Robert Kowalski; Sandra Milligan; Liza O'Dowd; Edward Reilly; Khyati Roberts; Andrew S Robertson; Mark Taisey; Roopal Thakkar; Karin Van Baelen; Max Wegner
Journal:  Clin Pharmacol Ther       Date:  2020-09-29       Impact factor: 6.903
  6 in total

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