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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.
May 08, 2017
The Identification of Medicinal Products (IDMP) standards requires regulatory teams to efficiently collate data from multiple sources and functions.
May 05, 2017
CPhI expert, Girish Malhotra believes drug costs could be lower if approval timeframes can be cut from 10 to three months.
EMA and the European Commission released a biosimilars information guide for health professionals during the EC’s biosimilars conference.
The agency sent a warning letter to Sal Pharma for not disclosing information about API manufacturers to customers.
May 02, 2017
Recent legislation and PDUFA initiatives aim to streamline oversight and testing requirements.
Siegfried Schmitt, PhD, Principal Consultant at PAREXEL, discusses how to gain benefits from interactions with industry associations.
Advances in chemical synthesis are enabling greener, more cost-efficient processes for API manufacturing.
New study will reveal bio/pharma practices and performance on quality issues.
Under US regulations, such as the Medicare Access and CHP Reauthorization Act of 2015 (MACRA), part of any US physician’s reimbursement will be based on patient outcomes.
Value-based medicine is putting patients at the center of pharmaceutical R&D and forcing the industry to move from treatment to prevention.