Getting overwhelmed by the news is an everyday struggle for those wishing to stay in touch with the latest news. Our newsletter should make it easier for those interested in pharmacovigilance regulations, advancement in the relevant use of artificial intelligence, and personal growth. Approaching with care, the same as we provide PV services, we thoughtfully pick articles every month to keep you updated.
Revised CTIS transparency rules and new version of the public portal. Concept paper on the revision of the COVID-19 vaccines guidance documents. Semaglutide linked to higher risk of blinding condition. Risk of AI getting dumber. And much more...
Presentation - Revised CTIS transparency rules and new version of the public portal
The Fee Regulation (Council Regulation (EC) No 297/95), and the Pharmacovigilance Fee Regulation (Regulation (EU) No 658/2014) determine EMA's fees. The legal framework applicable to the fees and charges payable to EMA is changing from 1 January 2025.
Concept paper on the revision of the COVID-19 vaccines guidance documents
Although AI models have made big breakthroughs in the last few years, there’s now a risk that they could get dumber and even collapse, according to a new research paper published in Nature. The phenomenon is described by researchers as “model collapse.” Think of it as a snake eating its own tail
AI-enabled medical documentation company Abridge, health IT giant Epic and healthcare system Mayo Clinic are partnering to create a genAI documentation platform that integrates Abridge's tools into Epic's EHR for Mayo Clinic nurses.
Emmanuel Bilbault, cofounder and CEO of POSOS, says the company's AI-powered clinical support platform offers alternate drugs to prescribe to avoid interaction risk, rather than simply alert doctors of possible medication errors.
A new study led by investigators from Mass Eye and Ear found that patients prescribed semaglutide (as Ozempic or Wegovy) for diabetes or weight loss had a higher risk of having a potentially blinding eye condition called NAION than similar patients who had not been prescribed these drugs.
A risk factor for a potentially fatal ventricular arrhythmia Torsade de Pointes is a prolongation in the heart rate-corrected QT interval (QTc) ≥ 500 milliseconds (ms) or an increase of ≥ 60 ms from a patient’s baseline value, which can cause sudden cardiac death. The Tisdale risk score calculator uses clinical variables to predict which hospitalized patients are at the highest risk for QTc prolongation.
This article reflects on the 2010 pharmacovigilance legislation of the European Union (EU). Its legislative aim of better patient and public health protection through new responsibilities for pharmaceutical companies and regulatory bodies is considered to have been achieved and is well supported by the good pharmacovigilance practices ‘EU-GVP’. For future progress, we set out a vision for high-quality pharmacovigilance in a world of ongoing medical, technological and social changes.
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