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Implications of regulatory and FDA guidance on diversity, equity and inclusion on clinical research study sites
Following discussions at the 2023 Global Site Solutions Summit, Missy Gottschlich, Director of Site Networks for Accellacare, provides key insights on how sites can implement regulatory guidelines on diversity, equity and inclusivity in this article in pharmaphorum.
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Confidently compliant? Considerations for industry players to meet the new EMA guideline
Vesta Marciulioniene, Director, Global Regulatory Clinical Services and Jo Hulbert, Executive Director, Global Regulatory Clinical Services provide an overview of the EMA’s new framework on computerised systems and electronic data in clinical trials in this article from XTalks Clinical Edge.
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Essential considerations for a successful submission under EU CTR
A key feature of the EU CTR is the introduction of a single electronic portal, the Clinical Trial Information System (CTIS), which is mandatory for all EU CTR submissions. CTIS enables harmonised and simplified end-to-end electronic application procedures over the lifecycle of clinical trials across the EU/EEA.
Published by International Biopharmaceutical Industry Journal Volume 6 Issue 2
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Comparing treatment performance through evidence synthesis
If there is a variety of treatment options in a specific disease area, decision makers require evidence of efficacy and safety of novel interventions in comparison to established treatments. One randomised controlled trial (RCT) is not sufficient to come to a final conclusion, especially since RCTs often present contradictory results.
Published by Journal for Clinical Studies Volume 15 Issue 2 (https://journalforclinicalstudies.com/).
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Regulatory considerations in technology for decentralised clinical trials
This article in the Journal of mHealth explores the guidance regulators have provided for diversity and inclusion in clinical trials, privacy considerations and endpoint selection, and is authored by Jo Hulbert, Executive Director, Global Regulatory Clinical Services with contributions from Arwa Shurrab, Senior Director, Global Regulatory Affairs and Priti Prasad, Senior Manager, Global Regulatory Affairs.
Copyright 2023 The Journal of mHealth (Simedics Ltd)
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‘Future protect': shoring up clinical programs against changes in standard of care
Kristen Buck and David Morse weigh in on how to avoid some recent pitfalls seen at US FDA advisory committee panels.
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How will NICE fare in a post-Brexit world?
In this article, ICON experts Caroline Delaitre-Bonnin, Emmanuel Lacharme and Manpreet Sidhu, consider how the UK drug pricing group, NICE, will be impacted post-Brexit.
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Global collaboration: Irish company ICON on scaling up COVID-19 vaccine trials
An interview in which Steve Cutler gives a short overview of ICON and describes the company’s role in the Pfizer/BioNTech trial, explaining how the FDA played a critical role in expediting regulatory approvals.
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US Regulators question AstraZeneca vaccine trial data
ICON's Dr. Andrew Garrett, Executive Vice President of Scientific Operations, weighs in on potential safety issues with the AstraZeneca COVID-19 vaccine.
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Overcoming IVDR challenges for companion diagnostics
Angela Brown, Global Head and Senior Director, Regulatory Affairs and Nicole Cowan, Director, Project Management, IVD Operations & Strategy, provide expert commentary on overcoming IVDR challenges for companion diagnostics.
