Medical Literature Monitoring

Medical literature is an important source of information on suspected adverse reaction case reports. As regulations are becoming more stringent, marketing authorization holders (MAHs) may face the challenge of incorporating ever-increasing safety data from literature into their pharmacovigilance (PV) efforts to achieve compliance. The quality and efficiency of the literature monitoring process has a significant impact on the quality of periodic safety reports, detection of new safety signals and eventually benefit-risk evaluation (BRE) of medicinal products. Importantly, shortcomings in this critical process have the potential to impact the MAHs overall PV activities including Regulatory compliance and potential impact on company reputation due to inadequate BRE of company products leading to potential drug recalls.