Eaf term request process
Download
1 / 7

eAF Term Request Process - PowerPoint PPT Presentation


  • 202 Views
  • Uploaded on

eAF Term Request Process. Presented by: Isabel Chicharo MDMS Lead Data Officer. Controlled Term Lists in use by eAF. Container category; Country Quantity operator; Units of Measurement; MRL Species; MRL provision; Tissue; Special precaution for storage Substances; Target Species

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about ' eAF Term Request Process' - quynn-petersen


An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
Eaf term request process

eAF Term Request Process

Presented by: Isabel Chicharo

MDMS Lead Data Officer


Controlled term lists in use by eaf
Controlled Term Lists in use by eAF

  • Container category; Country

  • Quantity operator; Units of Measurement; MRL Species; MRL provision; Tissue; Special precaution for storage

  • Substances; Target Species

  • Dosage form; Route of Administration; Container


Eaf term request process1
eAF Term Request Process

  • No CRs allowed: Container category; Country

  • Change request process:

    • Receive and approve (MDMS team): Quantity operator; Units of Measurement; MRL Species; MRL provision; Tissue; Special precaution for storage; Substances H

    • Receive and forward for internal approval: Substances V (EV Vet support); Target Species (CVMP)

    • Receive and forward for external approval: Dosage form (EDQM); Route of Administration (EDQM); Container (EDQM)


Eaf term request process user perspective
eAF Term Request Process – user perspective

* In the term request form there are detailed instructions on what information is required to apply for changes in each list.



Eaf term request form
eAF Term Request Form

  • Standard word form

  • Multiple terms can be requested at one time

  • 2. Product and application details

  • 3. Missing substances and excipients

  • 4. Missing terms for other drop downs

  • Indication of which eAF list it relates to

  • Indication of required details



ad