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Navigating the EU’s IVDR compliance deadlines amid uncertainty
With the COVID-19 pandemic, Brexit, and the rapidly approaching deadlines to comply with the new European Regulation on in vitro diagnostics (IVDR), IVD manufacturers will need to prepare for an ever-evolving clinical and regulatory landscape, and create mitigation strategies that allow for quick, agile changes to keep studies on track. Additionally, manufacturers will need to adopt a strategy to address gaps in meeting new regulations to avoid potential UK and European Union product availability issues. Understanding current guidance and adapted regulations is the first step to navigating the transformations undergoing the diagnostics field and the broader healthcare industry. In this article, Angela Brown and Nicole Cowan provide an overview of today’s regulatory setting and discuss how manufacturers can develop strategies to ensure a successful transition to comply with the IVDR by the 2022 deadline, including: overcoming the shortage of Notified Bodies; assessing product portfolios and quality systems; planning and implementing technical file remediation; and managing the IVD lifecycle.
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Moderna is designing a new version of its COVID-19 shot to fight the variant first found in South Africa
ICON’s David Morse, VP, Global Regulatory Affairs Consulting Services talks to Business Insider on regulatory pathways for development of new vaccines and vaccine boosters to address emerging COVID-19 variants.
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Vaccine trials were run to the highest regulatory standards
Dr. Nuala Murphy, President of Clinical Research Services, discusses how ICON carried out the COVID-19 vaccine trials.
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What clinical holds and pauses mean for COVID-19 countermeasure timelines
ICON’s Nuala Murphy and David Morse discuss trial pauses and clinical halts after three high-profile COVID-19 trials are temporarily halted as a result of potential safety issues being flagged by independent Data and Safety Monitoring Boards. Read more in this Biocentury article.
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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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