Firms should identify risks prior to inspection, make staff available during regulator visits, and respond promptly post-inspection when undergoing GMP site checks, says Ireland’s Health Products Regulatory Authority (HPRA).
TransCelerate’s new RBM (risk-based monitoring) methodology focuses on the use of technology and centralized monitoring to shift away from Source Data Verification (SDV) to risk-driven monitoring, according to two papers in the Drug Information Association's Therapeutic...
Three years after Pfizer began strategic partnerships with CROs Icon and Parexel, and the companies are still ironing out differences and tweaking their relationships, Mark Sanders, senior director of global sourcing, told attendees at DIA’s annual conference.
CROs and sponsors that apply a risk-based algorithm to monitoring clinical study sites could reduce the deployment of research associates and target more high-risk patients and sites, according to a new report from PricewaterhouseCoopers (PwC).
The ICH has approved a revision to its genotoxicity testing and data interpretation guidelines that it says will improve risk assessment and reduce the number of animals used during preclinical development.
The rise of the biotechnology industry is set to create additional
pressure on pharmaceutical companies, who already have to deal with
unreasonable expectations, where even common molecule failure in
the R&D stages result in loss...