Software Stories
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Industry newsFDA to establish Digital Health Advisory Committee
The FDA has established a Digital Health Advisory Committee to help the agency explore issues related to digital health technologies (DHTs).
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VideoChange Across the Medical Device Landscape
InnoScot Health protects the interests of NHS Scotland and believes it is crucial for innovators to get the right regulatory advice.
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Industry newsNeuralink gets FDA approval for its first brain device trials
Elon Musk’s Neuralink receives FDA approval to conduct a first clinical trial in humans of its experimental brain-computer interface ‘The Link’.
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FocusTranslating digitalisation trends into tangible solutions
Pharmaceutical companies are seeking to take advantage of digital innovations to become data-driven organisations, but rstly, they must overcome various data challenges to move from concept to execution. Timm Pauli, Head of R&D Informatics at PharmaLex, and Dr. Torsten Osthus, Advisory Consultant to PharmaLex and Managing Director of Osthus Group, (whose service division, Osthus Services, recently merged with PharmaLex), explore the path to successful R&D digitalisation.
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JournalThe national competent authorities of Belgium and Luxembourg share their views about the e-PIL Pilot
Q: Why do the authorities support the e-PIL Pilot and why do you think it is important? A: Iris Geussens: Digitalisation is the future, and the pharmaceutical sector cannot stay behind. The advantage of an electronic package leaflet is that you always have access ...
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JournalElectronic leaflet pilot in Belgium and Luxembourg hospitals
The e-PIL Pilot was set-up in Belgium and Luxembourg with the objective to demonstrate the equivalence between the paper patient information leaflet and the electronic patient information leaflet in providing information on the safe and effective use of medicines in hospital setting. The first results of the Pilot are promising ...