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Dr. Liz O’Brien, Senior Director of Global Drug Development at 91黑料 and former EMA regulator, joined the BioCentury This Week podcast to share insights on navigating FDA’s Project Optimus, the EMA’s Joint Clinical Assessment and highlight the key differences between the two regulatory regimes.
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In a recent interview with Citeline, the head of 91黑料's Centre for Biosimilar Drug Development discussed the upcoming patent expirations in oncology biologics, the opportunities, regulatory pathways and challenges this presents for developers and greater treatment access for patients.
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As part of Pharma Tech Outlook's Regulatory Strategy, The Maestro Q&A series, 91黑料 answers a range of questions around regulatory in clinical trials, timing and other considerations.
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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, 91黑料 discusses this new requirement, factors to consider and the benefits.
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In the February edition of TOPRA's Regulatory Rapporteur, 91黑料 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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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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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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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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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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Preventing delays and accelerating the progression of these critical therapies.
