MedDRA Blue Ribbon Panel

Welcome to the MedDRA Blue Ribbon Panel area. Blue Ribbon Panels (BRPs) have been developed to provide a forum for MedDRA experts from industry and regulatory authorities to discuss and make recommendations on challenging MedDRA issues on behalf of the user community.

BRPs are scheduled when feedback indicates the need for a broad discussion with resulting recommendations. Panel members are chosen by the MSSO, and BRPs are open to subscribers who wish to attend as audience members (observers).

As always, the MSSO appreciates feedback and suggestions for future Blue Ribbon Panel topics.

BRP7 Proposed Revisions to the Neoplasm SOC

BRP7 meeting took place on 12 April 2011 at European Medicines Agency in London, United Kingdom. The topic of this day-long meeting was proposed revisions to the Neoplasm SOC (SOC Neoplasms benign, malignant and unspecified (incl cysts and polyps)) based on input from a MedDRA user at the US National Cancer Institute.

The general discussion topics included:
    •  Delinking "cyst" terms from the Neoplasm SOC
    •  Adding more histologic specificity particularly at the PT level
    •  Improving and updating neoplasm classifications in MedDRA

The Panel members developed a set of recommendations for review by the MedDRA Management Board at their June 2011 meeting.

User Feedback on Proposed Neoplasm SOC Changes

The MSSO encourages all MedDRA users, and especially those involved with oncology products in development or on the market, to review a set of spreadsheets that describe potential changes to terms in SOC Neoplasms benign, malignant and unspecified (incl cysts and polyps) (Neoplasm SOC). These proposed changes reflect recommendations arising from the 7th MedDRA Blue Ribbon Panel held in April 2011.

Please provide your feedback to the MSSO Help Desk by Friday 13 April 2012. Refer to the explanatory note and spreadsheets detailing the proposed changes.

Meeting Agenda

Agenda

Background Document

Proposed Revisions to the Neoplasm SOC: Orientation to the Topic

Meeting Slides

MedDRA Blue Ribbon Panel: Proposed Revisions to the Neoplasm SOC

Panel Members

Members of this Blue Ribbon Panel were:

    Stewart Geary (Eisai)
    Jean-Marie Heim (Bristol-Myers Squibb)
    Sebastian Monzon (Roche)
    Gisele Sarosy (National Cancer Institute, USA [ret])
    Multiple FDA experts (FDA)*
    Atsuo Takashima (National Cancer Center, Japan)
    Kevin Blake (EMA)

[*Did not attend Panel meeting but FDA's input was presented]

Blue Ribbon Panel Archive