Adverse Events and Medical Errors Form

Instructions and help about Adverse Events And Medical Errors

so hello this talk is about the individual case safety reporting equality for suspect products and I'd like to start by acknowledging Harry Chiang Nitin Patel and Maggie Fung who are the data standards team regulatory science staff the learning objectives for the talk first we need to be able to identify which technical specification document pertains to electronic ICS our submissions then to understand the data fields and data sources for their ICS our product data elements and to describe the best practices in how to submit suspect product information so the document is specifications for preparing and submitting electronic ICS ours and ICS are attachments technical specification document it is available online and the most current version is from February this year the section on drug description has the following information so medicinal product field should contain the proprietary medicinal product name and the active substance name field the active drug substance name or names FD