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October 15, 2020
The IQ Consortium marks a decade of impactful innovation of collaboration through a network of pharmaceutical companies driving change for the bio/pharmaceutical industry.
Building employee participation and forming good habits contribute to a company-wide quality culture that pays off.
Find links to pertinent regulatory and standard setting resources, guidance documents, and guidelines.
Connect with pharmaceutical and healthcare regulatory authorities around the world via this directory.
October 09, 2020
Bio/pharma industry leaders support FDA’s newly published EUA guidance for COVID-19 vaccine authorization.
October 07, 2020
The guidance provides recommendations for data and information needed to support an EUA for COVID-19 vaccines.
October 02, 2020
The case for migrating from a paper-based quality management system to a digital platform is presented.
A comprehensive rewrite of Annex 1 has been proposed and aims to organize and structure requirements in 10 specific sections.
The amount of detail included in SOPs may help a company stay compliant, says Susan J. Schniepp, Distinguished Fellow at Regulatory Compliance Associates, LLC.
The guidance discusses acceptable clinical endpoints for demonstrating effectiveness of drugs developed to treat opioid use disorder.