MedDRA Blue Ribbon Panel Archive

BRP6 Extent of MedDRA Versioning and Feasibility of an Annual MedDRA Release

This meeting took place on 13 May 2009 at Schering-Plough Corporation, Kenilworth, NJ, USA. The topics of this day-long meeting were: 1. discussion of a draft document by MSSO describing the extent of MedDRA version updating processes and 2. the feasibility of a once-a-year release of MedDRA. The Panel's recommendations were reviewed and endorsed by the MedDRA Management Board.

Meeting Agenda

Background Documents

Extent of versioning: background and questions for Panel
MSSO draft recommendation on Extent of Versioning
Frequency of MedDRA release: background and questions for Panel

BRP Presentation

MedDRA Blue Ribbon Panel on Extent of Versioning and Feasibility of Annual Release

Panel Members

Barry Hammond (GlaxoSmithKline)
JoAnn Medbery (Johnson&Johnson)
Tom Paternoster (EMA)
Toni Piazza-Hepp (FDA)
Yasuo Sakurai (Japanese Maintenance Organization)

BRP 6 Recommendations

BRP5 Proposed Terminology Changes to Facilitate the Analysis of MedDRA-Coded Data

This meeting took place on 16 November 2006 at Boehringer Ingelheim Pharma GmbH & Co. KG, Germany. The topic of this day-long meeting was Proposed Terminology Changes to Facilitate the Analysis of MedDRA-Coded Data.

Agenda

BRP Reference Documents: 
BRP Concept Paper
Zhao-Wong, A.C., Rump, E., Moraleda, T., Mozzicato, P., and Revelle, P. Proposed Terminology Changes to Facilitate the Analysis of MedDRA ® -Coded Data. Drug Information Journal 2006 40: 291-303

BRP Presentation

BRP Summary

The Panel's recommendation of conducting a pilot study on implementing concept attribute relationships in MedDRA terminology was approved by the MedDRA Management Board. The MSSO conducted the pilot program (see below). For detailed information, please refer to the Concept Attribute Pilot Plan document.

Concept Attribute Pilot Study Summary:

In the pilot study, the MSSO analyzed the cost and level of effort for the de novo approach to establish diagnosis-test relationships, compared to those by exploiting existing relationships in National Library of Medicine's Unified Medical Language System (UMLS). In conclusion, both approaches are cost- and resource-intensive. Therefore, concept attributes are not feasible at present.

BRP4 CTCAE to MedDRA Mapping

This meeting took place on 6 April 2006 at Northrop Grumman's Fair Lakes facility in Fairfax, Virginia, USA. The topic of this day-long meeting was CTCAE to MedDRA Mapping.

For more information, please see the inks below.

BRP Reference Documents

CTCAE to MedDRA Mapping Concept Paper
Agenda
Summary of BRP Discussion on CTCAE-MedDRA Mapping
BRP Presentation

Panel Members

Ruthann Giusti (FDA)
Carmen Kreft-Jais (AFSSAPS)
Michelle Mahoney (Mayo Clinic Comprehensive Cancer Center)
JoAnn Medbery (Johnson & Johnson)
Bob Pratt (FDA)
Yasuo Sakurai (JMO)
Ann Setser (CTEP)
Philippe Thouvay (Roche)

CTCAE v3.0 Revision Information Board

CTCAE Working Group Teleconference Meeting (8 July 2008)

CTCAE Version 3 Vocabulary Standards Review (11 July 2008)

CTCAE V3.0 Revision Project (11 July 2008)

CTCAEv4.0 is posted on the CTEP Web site.

CTCAEv4.0 related documentations are posted on the NCI EVS Web site.

BRP3 MedDRA and Product Labeling: Best Practices

This meeting took place on 16 March 2005 at AstraZeneca's facility in Zoetermeer, the Netherlands (near Amsterdam). The topic of this day-long meeting was MedDRA and Product Labeling: Best Practices.

For more information, please see the links below:

Agenda
MedDRA and Product Labeling: "Best Practices" Recommendations
Can MedDRA be used for Labelling? Should it?
Presentation property of Dr. Sidney Kahn, Pharmacovigilance & Risk Management, Inc.

Panel Members

Dr. A. Leander Fontaine, Wyeth Research
Dr. Med. Reinhard Fescharek, Bayer HealthCare AG
Ms. Melissa M. Truffa, R. Ph., FDA
Mr. Yasuo Sakurai,  Japanese Maintenance Organization (JMO)
Dr. Ineke Crijns, MD, MFPM, Medicines Evaluation Board, the Netherlands

BRP3 Meeting Summary
MedDRA Management Board Statement
Blue Ribbon Panel: MedDRA and Product Labeling: Best Practices

BRP2 MedDRA Modifiers

A MedDRA Blue Ribbon Panel (BRP) meeting was held on 18 June 2004 in Reston, Virginia, USA to discuss the MedDRA Modifiers concept. In addition to Blue Ribbon Panel members and MSSO staff, there were approximately 40 MedDRA subscriber observers in attendance.

The BRP began by discussing some of the proposed options for approaches to modifiers implementation outlined in the concept paper. The focus of discussions later switched to alternate ways to achieve the modified terms specifically requested by the MedDRA user community through a planned process that would involve subscriber input.

Subsequent to the meeting, the Panel drafted a report to the MedDRA Management Board that recommended steps to proceed with this alternate approach to adding modified terms to MedDRA.

MedDRA Modifiers Document

BRP Members

Christina Winter (EU Industry)
Hilary Vass (EU Industry)
Yasuo Sakurai (JMO)
Kostas Kidos (US Industry)
Sabine Broche (EMEA)
Andrea Feight (FDA)
Greg Gribko (US Industry)

BRP1 First MedDRA Blue Ribbon Panel Meeting

BRP1 Recommendations