1 / 6

Draft Important Medical Event (IME) list – Public consultation

Draft Important Medical Event (IME) list – Public consultation. Updated to MedDRA version 13.0. What has been done since version 12.0?. Drafting of inclusion and exclusion criteria Finalisation of the IME list now updated to MedDRA version 13.0: 10101 PTs (about 30% ES, 70% CS)

oya
Download Presentation

Draft Important Medical Event (IME) list – Public consultation

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. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Draft Important Medical Event (IME) list – Public consultation Updated to MedDRA version 13.0

  2. What has been done since version 12.0? • Drafting of inclusion and exclusion criteria • Finalisation of the IME list now updated to MedDRA version 13.0: • 10101 PTs (about 30% ES, 70% CS) • To obtain a copy of these documents, please send an email to • MedDRAIMElist@ema.europa.eu Important Medical Event (IME) list

  3. Finalisation of inclusion/exclusion criteria • MSSO has developed a set of overall inclusion/exclusion criteria + SOC specific criteria and updated them to v. 13.0 (in yellow sign. changes) • These now apply also to: • SOCs excluded in full in v. 12.0: • SOC Social circumstances • SOC Surgical and medical procedures • SOCs included in full in v. 12.0: • SOC Congenital familial and genetic disorders • SOC Neoplasm benign, malignant and unspecified (incl. cysts and polyps) • SOC Infections and Infestation Important Medical Event (IME) list

  4. Finalisation of IME list v. 13.0 (I) • Methodology applied at the MSSO: • Review all the PTs in MedDRA v. 12.1 against the newly developed incl./excl. criteria and ADD/DELETE terms as applicable • The newly v. 12.1 added terms based on this review are in red, blue, and green font • Identify new PTs in MedDRA v. 13.0 that fit the incl./excl. criteria and ADD them as applicable. • These are designated with an “x” in column labeled “added v.13.0” Important Medical Event (IME) list

  5. Finalisation of IME list v. 13.0 (II) • See if for any of the PTs which had been demoted to LLT, the current “parent” PT was already included in the IME list or should otherwise be included. Also changes in primary SOC for the terms were noted • Complete the designation of ES/CS also for newly added terms from SOCs Social circumstances and Surgical and medical procedures Important Medical Event (IME) list

  6. Input needed from public consultation • Please provide your comments (and specify in the subject of your email “comments on IME list, version 13.0”) toMedDRAIMElist@ema.europa.euby10th September 2010on: • The final IME list, MedDRA v. 13.0: please provide your comments in the column of the spreadsheet labelled “Comments from public consultation (in case of disagreement)” • The inclusion ad exclusion criteria: please provide your comments in the word document using the track changes activated Important Medical Event (IME) list

More Related