Pharmaceutical companies often donate their products to those in dire need, but it hasn’t been especially clear how adverse events for donated products should be handled. In light of recent public health programs to fight neglected tropical diseases, the World Health Organization (WHO) asked the European Medicines Agency (EMA) to clarify the marketing authorization […]
Posts Tagged ‘adverse event reporting’
Regulatory Reporting Rules In Argus Safety
In Argus Safety, all of the parameters for configuring the worldwide regulatory reporting rules are clearly identified on a single administration screen. You have the capability of selecting various case or event-level attributes, as well as using very advanced conditions, to focus the automated triggering of these report rules in various circumstances.
Medical Review In Argus Safety
Much like the Coding Review screen, the Medical Review screen is functionality in Oracle’s Argus Safety that displays the relevant case in a single central window and allows a medical reviewer to see all of the key data points that he or she would use when assessing the case.
When Supplement Manufacturers, Not Athletes, Cheat
A recent article in Forbes reported that an astounding percentage of dietary supplements do not contain the main ingredient listed on the label. That’s concerning, considering there aren’t too many stringent regulations they have to follow, unlike pharmaceutical companies.
Perficient’s Top 10 Life Sciences Blog Posts of 2014, Letterman-Style
As we wrap up 2014, I thought it would be neat to see what our readers were, well, reading. Without further ado, here are the top 10 blog posts Perficient’s life sciences practice wrote that seemed to be popular among readers. They’re ranked David Letterman-style, one being most popular (i.e., viewed). The One Feature CROs and […]
4 Ways To Submit A MedWatch 7-Day Report
Over the years we have seen some general confusion regarding the use of the FDA MedWatch 7-day report for fatal blood collection or transfusion reporting versus the standard 7-day alert requirement for FDA individual case safety reports from IND trials. Some of the safety systems that our company has worked with over the years do […]
Canada’s New “Vanessa’s Law” Contains New Adverse Event Reporting Requirements
On November 6, 2014, Canada passed Vanessa’s Law, a new piece of legislation designed to protect patients from unsafe drugs and medical devices. The law comes after many complaints from citizens that the country wasn’t doing enough to oversee the safety of products sold in the marketplace or the clinical trials being conducted in the […]