Structured Product Labeling SPL
When discussion takes on to Structured Product Labeling (SPL) often most of our thoughts move to prescribing information. However the US food and drug administration (USFDA) and other regulatory authorities overhaul review procedures, electronic fillings are having a strong effect on the communications.
Considerations in RBM Implementation
In this 5th Edition of Applied Clinical Trials' eBook on Risk-Based Monitoring in Clinical Trials, articles cover the advances that have been made in RBM since guidances' released in 2013. How is pharma implementing RBM - is it more remote, centralized or a combination? Read the article by Dr. Ashok Ghone, Vice-President, Global Services at MakroCare:Considerations in RBM Implementation