On-Demand Webinar: Continuous Improvement of Pharmacovigilance Systems – E2B (R3) Compliance with Total Safety 7.2
Over the last decade as the volume of adverse event reports has increased, more and more companies have shifted from paper-based submissions to electronic reporting and electronic exchange of tracking records. Electronic submissions have become a very important element of Global Pharmacovigilance and as such, the ICH E2B (R2) guideline that was released in 2001 has been widely used for regulatory compliance purposes for several years. The standard has evolved and now we have ICH E2B (R3).
The focus of this webinar is the new E2B (R3) electronic standard that would come into force for the exchange of pharmacovigilance information between and among the pharmaceutical industry and the regulatory authorities from 2016. We will look at the hierarchical structure of E2B (R3) format at a very high level and see some of the key improvements made to this standard over its predecessor E2B (R2). In addition, we will look at the key enhancements made to ArisGlobal’ s Total Safety 7.2 release to implement this new standard. This webinar will include –
– Glance through key changes made to ICSR structure in ICH E2B (R3) Specifications
– Review key enhancements made to the Total Safety 7.2 for E2B (R3) Compliance
– Showcase other enhancements made to the ARISg safety system
We will also take a look at few other enhancements in the Total Safety Suite to support reporting and data extraction such as the newly optimized Reporting and Analytics Platform, agHub.
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