Remove tag pharmaceutical-quality-systems
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STAT+: FDA scolds Sun Pharmaceutical for serious quality control problems at a key plant in India

STAT News

Sun Pharmaceutical, one of the world’s largest generic drugmakers, was scolded by the U.S. Food and Drug Administration for a host of serious manufacturing violations at a key plant in India, the latest instance in which the company was tagged by the regulator for quality-control problems.

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Smart pharmaceutical and healthcare labels: Lets trace medicines from its origin

Roots Analysis

Traditionally, text and images were printed on pharmaceutical products to convey important information. It is worth noting that smart labels contain a transponder code which can be read by sophisticated devices, including radio frequency identification device (RFID) tags and near-field communication (NFC) chips.

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Upcoming sickle cell gene therapies cost effective at $2 million, says ICER

Pharmaceutical Technology

Released on April 12, the report focuses on bluebird bio’s lovotibeglogene autotemcel and Vertex Pharmaceuticals and CRISPR Therapeutics’ exagamglogene autotemcel or exa-cel and their potential use in treating sickle cell disease. million to achieve $150,000 per QALY gained from a healthcare system perspective.

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How automation can help to address supply chain challenges in pharma

pharmaphorum

Supply chain issues have been rife in pharmaceuticals for a while, but current socio-economic challenges such as the conflict in Ukraine and the COVID-19 pandemic have led to extended wait times and higher prices for thousands of products. Here’s how applying automaton in pharmaceutical labs can help address these.

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Grand Rounds August 18, 2023: Opportunities to Improve Clinical Trials: Draft Revision of the ICH Good Clinical Practice Guideline (E6R3) (Prof Sir Martin Landray, FMedSci; M. Khair ElZarrad, PhD, MPH)

Rethinking Clinical Trials

The International Council for Harmonisation of Technical Requirements for Human Use (ICH) is a unique harmonization organization involving regulators and the pharmaceutical industry. Clinical trials should incorporate quality in their scientific and operational design, conduct and analysis. – What are the next steps?

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Grand Rounds August 18, 2023: Opportunities to Improve Clinical Trials: Draft Revision of the ICH Good Clinical Practice Guideline (E6R3) (Prof Sir Martin Landray, FMedSci; M. Khair ElZarrad, PhD, MPH; Adrian F. Hernandez, MD, MHS)

Rethinking Clinical Trials

The International Council for Harmonisation of Technical Requirements for Human Use (ICH) is a unique harmonization organization involving regulators and the pharmaceutical industry. Clinical trials should incorporate quality in their scientific and operational design, conduct and analysis. – What are the next steps?

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AI-Powered Precision Engagement in Commercial and Medical Functions

Intouch Solutions

The pharmaceutical industry is no stranger to innovation. Clinical : Optimized efficiency, inventory management, and service quality of clinical trials. Importantly, these materials do not need to originate solely from pharmaceutical companies but can also come from external sources. How is AI being used in precision engagement?