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It is important to understand the differences between risk-based decision making and other decision making in a pharmaceutical quality system.
Validating computerized systems is required to demonstrate adherence to data integrity, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.
Quality-by-design risk assessment workflows can be laborious and have limited capacity to connect with vast volumes of prior knowledge generated by organizations. ecosystem.
November 18, 2020
The agency’s safety monitoring plan outlines how information that emerges after the authorization of COVID-19 vaccines will be collected and reviewed.
EDQM announced three new Official Control Authority Batch Release guidelines that describe the tests to be performed by Official Medicines Control Laboratories in the European Union OCABR Network.
The agency recommended treatments for a variety of cancers as well as treatments for glaucoma and influenza.
The guidance was published in connection with a safety monitoring plan for COVID-19 vaccines.
The agency marked the annual European Antibiotic Awareness Day with the launch of a social media campaign highlighting the prudent use of antibiotics.
November 12, 2020
The first public announcement from the Biden-Harris transition team was to name members of a COVID-19 advisory board charged with initiating policies and actions to combat the fast-rising infection rate in the United States
AstraZeneca has received approval for Calquence (acalabrutinib) to be used as a treatment of chronic lymphocytic leukemia (CLL) in adults within the European Union (EU).
November 06, 2020
Opposition to IP protection for COVID-19 vaccines, therapies, tests and other technologies may only prevent eradication and treatment of the disease.
The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted a Type II variation application to EMA for expanded use of the SC formulation of Darzalex.
November 04, 2020
At the 2020 Bio/Pharma Virtual Congress, experts discuss the importance of characterizing excipients to ensure quality, safety, and effective performance.