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Loredana Bergamini

@unaLoredana

Physician #ClinicalResearch #HealthScience lover. Connecting Sharing & Learning on Twitter

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Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products fda.gov/regulatory-inf…


Loredana Bergamini Reposted

Anche uno studio che ha fornito risultati negativi conta nel metodo scientifico e nel processo di costruzione delle conoscenze. @forwardRPM forward.recentiprogressi.it/it/rivista/num…

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Loredana Bergamini Reposted

Fai la tua parte per combattere l' #antibiotico-resistenza: non prendere gli #antibiotici di tua iniziativa. Segui sempre le prescrizioni del tuo medico 📺Guarda lo spot con Francesca Fagnani realizzato da #AIFA e @MinisteroSalute👇 bit.ly/waaw23 #KeepAntibioticsWorking


Loredana Bergamini Reposted

When developing new drugs, it is crucial to incorporate the patient’s voice and perspective. Learn more about how the FDA's PFDD program collects input from providers, patients, and caregivers in developing and advancing effective treatment options: fda.gov/drugs/developm…

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Loredana Bergamini Reposted

New paper "Digital Therapeutics : Scientific, Technological, And Regulatory Challenges” just published by @SpringerNature in the book "Personalized Medicine Meets Artificial Intelligence - Beyond Hype, Towards the Metaverse" #DTx link.springer.com/book/10.1007/9…


Loredana Bergamini Reposted

The data from many randomized clinical trials are seriously flawed, some even fabricated "zombies". A new @Nature feature probes this serious issue and the importance of access to and reviewing individualized participant data nature.com/articles/d4158… by @Richvn

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Loredana Bergamini Reposted

✅L’Italia ha eliminato la #rosolia, che non è più endemica 🗣Lo ha annunciato la Commissione di verifica regionale @WHO 🎯Un importante traguardo per il nostro Paese che mostra ancora una volta il valore protettivo dei #vaccini 🔎Leggi la notizia👇 bit.ly/ItaliaRosoliaF…

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Loredana Bergamini Reposted

Investigating the origins of recent pharmaceutical innovation bit.ly/3D22C9q An analysis of new drugs from the top 20 biopharma companies indicates that their business model in recent years has largely been built on external innovation, as only 28% originated internally

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Loredana Bergamini Reposted

Today, FDA announced the availability of a draft guidance with updated recommendations aimed at modernizing the design and conduct of clinical trials, making them more agile without compromising data integrity or participant protections: fda.gov/news-events/pr…

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Loredana Bergamini Reposted

Loneliness is as toxic as smoking 15 cigarettes a day


Loredana Bergamini Reposted

Do we need a new definition of #PublicHealth? Considering the ever-changing nature of public health issues, there is an 'urgent need' for re-assessing public health definitions to fit the present global society @RaziehAzari @BBorisch in @BioMedCentral archpublichealth.biomedcentral.com/articles/10.11…

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WHO advises not to use non-sugar sweeteners for weight control in newly released guideline who.int/news/item/15-0…


Loredana Bergamini Reposted

A @NatureMedicine feature article discusses how rare-disease researchers are moving away from randomization and placebo groups in clinical trials in favor of biomarkers, real-world data from wearables, and multi-center and adaptive trials. go.nature.com/41hbSjV


Loredana Bergamini Reposted

This new FDA Voices piece discusses two papers on artificial intelligence (AI) and machine learning (ML) in drug development and manufacturing: fda.gov/news-events/fd…


Loredana Bergamini Reposted

Today, FDA issued a discussion paper intended to initiate communication surrounding artificial intelligence and machine learning (AI/ML) with stakeholders, including industry and academia, to promote mutual learning and discussion: fda.gov/media/167973/d…

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Loredana Bergamini Reposted

We're taking additional steps to support the use of decentralized clinical trials (DCTs) for drugs, biologics & devices, where some or all the trial-related activities occur at locations other than traditional clinical trial sites. fda.gov/news-events/pr…


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