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5 Things To Know About Antimicrobial Stewardship Regulatory Standards

IDStewardship

In 2015 a National Action Plan for Combating Antibiotic Resistant Bacteria was released, known as CARB. The most recent CARB addresses the years 2020-2025, building upon the initial one released in 2015. The latest antimicrobial stewardship regulations from The Joint Commission went into effect in January 2023.

Hospitals 236
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How common are changes to the primary endpoint in oncology RCTs?

Hospital Pharmacy Europe

In a 2015 systematic review of registered and published outcomes in randomised trials, researchers found that discrepancies between registered and published outcomes of clinical trials were common. Nevertheless, it is incumbent on trialists to communicate such changes. Later work simply re-affirmed this finding.

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Highlights from ESCMID Global 2024: AI, climate change and AMR

Hospital Pharmacy Europe

In 2014 and 2015 Professor Claverie’s team revived a 30,000-year-old virus, leading to media attention about so-called ‘zombie viruses’. In microbiologically documented HAIs, 32% of microorganisms were resistant to antimicrobials. However, as the planet warms, the permafrost thaws, releasing these ancient viruses into the atmosphere.

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Theranos founder Elizabeth Holmes guilty of fraud, says jury

pharmaphorum

They also used direct communication, marketing materials, media and financial statements, models and other information to defraud potential investors, according to the complaint. She admitted using pharma company logos – including Pfizer – on Theranos documents sent to investors, even though they had not endorsed the technology.

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Streamlining Postapproval Submissions Using ICH Q12 & SCDM

ISPE

For changes requiring approval before implementation, once the necessary information has been submitted across regions, each health authority must review the data package and documentation based on local requirements. laboratory notebooks, batch records, and technical reports) to submission documents (e.g., Accessed 7 September 2021.

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Removing Regulatory Hurdles for Continuous Pharmaceutical Manufacturing

ISPE

Owing to the engagements through the ETP and the addition of key personnel with experience in CM in the petrochemical industry, CDER approved the first regulatory submission incorporating CM for a small molecule drug product in 2015. 3 (2015): 840–49. Published 8 October 2015. 3 (2015): 792–802. 2 Kuehn, S. 5 Rosas, J.

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Pharma 4.0™ Is Gaining Momentum and Driving Innovation

ISPE

™ started in 2015 at the ISPE Germany/Austria/Switzerland (D/A/CH) “Plug and Produce” workshop in Basel, Switzerland. Then in 2015, ISPE in Europe founded the Special Interest Group (SIG) Pharma 4.0™, and management communication strategy. Is the vendors’ documentation complete in order to assess GxP risks and GxP compliance?