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Regulatory Strategy, The Maestro
As part of Pharma Tech Outlook's Regulatory Strategy, The Maestro Q&A series, ICON answers a range of questions around regulatory in clinical trials, timing and other considerations.
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Preparing to Achieve with Joint Clinical Assessments
Since Regulation (EU) 2021/2282 (HTAR) came into effect, HTDs need to plan for a Joint Clinical Assessment (JCA) in addition to submitting their CTD to the EMA or medical device technical file to their notified body. In this article, ICON discusses this new requirement, factors to consider and the benefits.
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Regulatory strategy implications for foetal medicine
In the February edition of TOPRA's Regulatory Rapporteur, ICON summarises the European legislation related to Regulation (EC) 1901/2006 and how it incorporates PIPs but omits the unborn foetus. We also review the guidelines and other application precedents while providing insight into distinctions that may be made by the agency in this matter, as well as highlighting relevant precedents which were identified during this peer reviewed article.
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Set for success. Avoiding the pitfalls of clinical data conformity in medical device trials
It would seem intuitive that in order to pass a clinical trial and be compliant with EU MDR/IVDR, the trial data would need to conform to the processes and rules set out by the Notified Bodies. Surprisingly, in practice this is not always the case. Learn more about potential pitfalls and how to mitigate against them.
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Developing Robust Submission Strategies for Combined Studies
Medical interventions increasingly involve the use of technology and devices. New treatments may involve a medical device, combination product or in vitro diagnostic device. For sponsors this means their studies have additional regulatory requirements to meet, each on very distinct submission pathways. Read the full article.
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Understanding EU regulatory requirements for studies with medical devices and in vitro diagnostic devices
Treatments are being developed that use medical devices, combination products and in vitro diagnostic medical devices. However, before patients benefit from these new treatments, use of these devices within clinical trials is subjected to scrutiny by different regulatory agencies.
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Innovation and flexibility in long-term follow-up studies
Read insights from Harpreet Gill VP, Real World Solutions, on how sponsors can optimise their LTFU studies to be flexible and cost-effective, with strategic planning and innovation, overcoming challenges while capturing valuable data insights.
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Cover Story - Regulatory CMC: Enhancing Biologics Development
Preventing delays and accelerating the progression of these critical therapies.
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The future of RWD and RWE in healthcare decision-making: Applications of novel real-world data collection methods for healthcare decision-making
Read insights from Jennifer Eriksson, Divisional Principal, on the use of real-world evidence and real-world data to inform healthcare decision-making and provide patients with rapid access to innovative healthcare technology.
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ICON interview: Insights on the new EMA guidelines for computerised systems and electronic data in clinical trials
Outsourcing Pharma spoke to Vesta Marciulioniene, director global regulatory clinical services at ICON Biotech, who shares her insights on the new EMA guideline for computerised systems and electronic data in clinical trials and what new expectations it sets for the clinical research industry.
