Consultation open
Considerations for the Selection of IMDRF Adverse Event Terminology
The objective of this document is to provide further guidance on the correct application and consistent use of the terminology. The document provides guidance for all stakeholders:
• providing general coding principles on reporting incidents using IMDRF codes;
and
• providing examples to address common coding challenges.
*Note consultation period extended to 90 days
Consultation documents
Considerations for the Selection of IMDRF Adverse Event Terminology
Please use the comments template to provide comments on the Proposed Document and send comments to
- Nancy A. Pressly, Food and Drug Administration (FDA), United States of America, Nancy.Pressly [at] fda.hhs.gov (Nancy[dot]Pressly[at]fda[dot]hhs[dot]gov)
- Andrea Hanson, Health Products Regulatory Authority (HPRA), Ireland, European Union, Andrea.Hanson [at] hpra.ie (Andrea[dot]Hanson[at]hpra[dot]ie)
- Graham Nash (Maintenance Chair), Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom, graham.nash [at] mhra.gov.uk (graham[dot]nash[at]mhra[dot]gov[dot]uk)
with the subject line 'Public Consultation on “Considerations for the Selection of IMDRF Adverse Event Terminology'
Considerations for the Selection of IMDRF Adverse Event Terminology - Consultation Template
- docx (35.72 KB)