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In the News
ICON experts frequently author or contribute to industry trade press.
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Encouraging patient participation in real world studies
Real world data is rapidly becoming the latest frontier for life sciences companies for supporting regulatory filings and conducting drug safety surveillance. ICON experts discuss the critical role of patients and advocacy groups in the June issue of Pharmaceutical Market Europe.
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Going through changes
ICON's Angela Brown considers what manufacturers can learn from medical device regulation (MDR) and the effect it will have on the in vitro diagnostic landscape (IVD)
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The importance of partnering for bioanalytical studies
BioPharm International speaks with ICON's Robert Kernstock about the need for bioanalytical testing programs and regulatory strategies for potential new biologics.
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The U.S. biosimilars market: Shaking the “laggard” label
An article by Katya Svoboda and Bob Swann which explores the fundamental differences in the regulatory processes and the market dynamics of the US and the EU which account for much of the discrepancy in the uptake of biosimilars.
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The Significant Role of a Robust Regulatory Intelligence Process in Global Safety Submissions
Pharmacovigilance insights on the efforts towards the international standardisation of electronic transmission of drug safety information to achieve a unified objective of patient safety, written by Arinder Sihota and Trupti Gurjar, which featured in the March 2020 edition of Pharma Focus.
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Navigating an Ever Evolving Regulatory and Pharmacovigilance Landscape
In the 2020 edition of SCRIP Asia 100 ICON's Chuhua Wu outlines the variations in the structures, processes and outcomes of the pharmacovigilance status among Asian countries, with many diversities and complexities, and how a trend toward a more stringent regulatory environment in Asia is predicted.
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A Strategic Business Plan to ensure success under MDR/IVDR
David Novotny and Angela Brown share their insights in this Medical Design and Outsourcing article as to how manufacturers can develop a strategic business model that will prepare them for success under the new MDR/IVDR reforms
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Assessing The Impact Of MDR & IVDR On Patients
In Diagnostics World's recent article featuring commentary from ICON experts David Novotny, Angela Brown and Nicole Cowan, they discussed the need to assess the impact of MDR/IVDR on patients after the new medical device regulation is established.
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Regulatory bottlenecks mean EU clinicians & patients could lose access to medical devices under new rules
A recent press release by Samedan LTD Pharmaceutical Publishers on ICON’s scheduled presentation to be given at The Medtech Conference 2019, ‘MDR/IVDR – What now?’, during which our experts will discuss the findings of the whitepaper ‘Higher Costs & Bottlenecks’, looking at the future implications of the new MDR/IVDR rules on the EU market.
