Literature is regarded as a significant source of information in the monitoring of a medicinal product, its safety profile, and benefit-risk balance. Literature surveillance can be a key tool for the detection of new or emerging safety signals/issues.
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Case Study
PRA Leads Novel Multiple Myeloma Drug Development
PRA Health Sciences supported 2 multiple myeloma clinical trials, a Phase III and a “rollover,” for a large biotech client. This management contract…
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Webinar
Practical Implementation of Signal Detection in Iterative Benefit Risk Evaluation
This webcast with PRA Health Sciences' Jacinta Aniagolu-Johnson (Senior Director, Safety and Risk Management) explores how a well defined signal…
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Newsletter
Pharmacovigilance Nugget #3 The Challenges of Effective PSMF Maintenance - December 2018
The Pharmacovigilance System Master File (PSMF) is a legal requirement in the European Union (EU). A PSMF shall describe the pharmacovigilance (PV)…
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