• CTCAE Working Group Teleconference Meeting  (8 Jul 2008)
  
  
• CTCAE Version 3 Vocabulary Standards Review  (11 Jul 2008)
  
  
CTCAE V3.0 Revision Project  (11 Jul 2008)



CTCAE Revision Schedule   (20 Oct 2008)

Phase 1: July 5 – Sept.10, Working Group develop CTCAEv4.0 draft 1

Address CTCAE v3.0 Terms only
Represent terms as single concept MedDRA terms

Phase 2: Nov. 3 – March 13, Working Group develop CTCAEv4.0 draft 2

Address Grading (severity) scales
Add new terms

CTEP Help Desk Requests
Others

Also Consider, Remarks, Navigation Notes, Others

Public Review: April 9 – May 6
Phase 3: May 7 – May 26

Working Group; Steering Committee; Advisory Board Review

Final: May 27 - Publication

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)

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.
  pvrm@comcast.net



• 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 began work on a report to the MedDRA Management Board that will recommend steps to proceed with this alternate approach to adding modified terms to MedDRA; this document is still in progress as of 28 July 2004.

• MedDRA Modifiers Document