Pooling meaningful data from vast Pharmacovigilance database for Regulatory periodic reports
There exist regional and universal guidelines emphasizing the type and
Mechanism to extract adverse experience reports output for US FDA
Periodic safety reports are prepared as a part of periodic
Solution to Periodic safety submissions (PADER/PAER reports) through eCTD submission software
The Regulatory industry is witnessing huge transformations. Some new regulations
Pharmacovigilance discipline merger with IT would witness major electronic transformation
E2B XML was a remarkable turning point in pharmacovigilance for
Branded softwares in Pharmacovigilance: Are we being unduly ‘overgenerous’ in name of Regulatory compliance!
This blog presents Industry expert’s views and expresses their opinions
Gearing up for a smooth transition to ISO-IDMP standards: Planning step-wise
In pharmacovigilance and in this industry largely, striking a regulatory
Pharma/Biotech Industries to modulate their operations to suit the massive pharmacovigilance headway
Product safety has geared up to what we call ‘optimal’
Questions & Answers Blog on recent webinar on ‘Impetus to Literature surveillance in pharmacovigilance on wheels of automation’
These are few of the questions raised by Webinar audience
Surpass limitations of Literature monitoring in Drug safety with flexible and versatile approach
With the advent of technology, we are cocksure to upgrade
Questions & Answers of webinar (Feb 2015) on Signal detection methodology: Current and Novel approaches
This Questions & Answers Blog are from Signal Detection Webinar