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Understanding the Impact of the New EU Artificial Intelligence Act on Clinical Research

Advarra

The EU AI Act’s implications extend into clinical research, where AI is increasingly utilized for tasks like medical image analysis, natural language process for endpoint analysis, and generating/analyzing data for synthetic control arms. Non-EU companies must comply with the AI Act if their AI systems are used in the EU market.

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From cradle to grave: Novo Nordisk Foundation and cardiometabolic diseases 

Drug Discovery World

Following a trip to Copenhagen, Denmark, DDW’s Megan Thomas reflects on the Novo Nordisk Foundation’s efforts to tackle cardiometabolic diseases. The World Health Organization (WHO) reports that cardiovascular diseases (CVDs) are the leading cause of death globally, stating that an estimated 17.9 million).

Disease 162
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Scaling up: The need for human cells to give better access to cell therapies

Drug Discovery World

Cell therapies have emerged as transformative and potentially curative treatments across a range of disease areas. She and bit.bio are going beyond this cell type and looking at producing other cell types which may provide answers to a range of diseases beyond blood cancers.

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Sequana Medical to present at Jefferies 2020 Virtual London Healthcare Conference

The Pharma Data

About Sequana Medical Sequana Medical is a commercial stage medical device company developing the alfa pump platform for the management of fluid overload in liver disease, malignant ascites and heart failure where diuretics are no longer effective. and EU5 by 2026. GHENT, Belgium, Nov.

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Sequana Medical Announces January 2021 Investor Conference Schedule

The Pharma Data

About Sequana Medical Sequana Medical is a commercial stage medical device company developing the alfa pump platform for the management of fluid overload in liver disease, malignant ascites and heart failure where diuretics are no longer effective. and EU5 by 2026. GHENT, Belgium, Dec.

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Sequana Medical Appoints Two Additional Experts as Heart Failure Scientific Advisors

The Pharma Data

15, 2020 (GLOBE NEWSWIRE) — Sequana Medical NV ( Euronext Brussels: SEQUA ) , an innovator in the management of fluid overload in liver disease, malignant ascites and heart failure, today announces the appointments of Dr. Michael Felker and Dr. James Udelson as new Heart Failure Scientific Advisors. and EU5 by 2026.

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Article FDA Thank You FDA updates set the stage for broader use of harmonized standards for safety reporting

Agency IQ

The FDA created a parallel tool, called the eSubmitter which worked like the SRP with the caveat that case information was not uploaded to FAERS but to the Vaccine Adverse Event Reporting System (VAERS), a program co-monitored by both the FDA and the Centers for Disease Control and Prevention (CDC). database-to-database submissions).

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