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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 02, 2016
Vendor selection and materials testing are complex enough, but in today’s volatile environment, risk mapping and monitoring are also crucial.
Outcry against high pharmaceutical pricing brings questions of high R&D costs and restrictive payers, but also drug development and manufacturing efficiency.
Recent astronomical price increases have driven accusations that some pharma companies are price-gouging.
Covert and layered approaches to combat drug counterfeiting and illegal diversion strive to stay ahead of criminal enterprises.
Governments stretch limited resources to track counterfeit, diverted, and stolen pharmaceuticals globally. \
Robust data integrity begins with both management and employees embracing a quality culture and successful implementation of data governance measures.
The biosimilar pathway permits licensure based on less than full clinical data.
The proliferation of counterfeit medicines is nothing new to pharma; however, the scale of the problem seems to be escalating.
November 01, 2016
TraceLink launched the EU-hosted early access program to reduce the time, cost, and risk of achieving regulatory compliance for global requirements.
Douglas C. Throckmorton, MD, provides some key facts about abuse-deterrent opioids.