ICH Q3D IWG Work Plan

15 March 2015
Topic Adopted: October 2009
Last Face-to-Face Meeting: Minneapolis, June 2014
1. Anticipated Milestones
Completion Date

Deliverable

26 July 2013

Step 2 Guideline

16 December 2014

Step 4 Guideline

21 October 2014

IWG endorsed by ICH Steering Committee

4 June 2015

Finalize Q3D Training Material

2. Timelines
Date

Task / Activity

Details

6 January 2015 Weekly conference calls to

21 May 2015
discuss training material

Small project teams have been

established to develop 7 modules
addressing 7 aspect of Q3D. Case
studies and the responses to common
questions are also under development.
The teams work off line to advance the
training materials. Every 2 weeks, the
safety and Quality sub teams meet
separately by teleconference to discuss
the safety and quality modules and
provide feedback to the project teams.
The full IWG meets biweekly to discuss
overall progress and responses to
common questions.

1 4 June 2015

By June it is anticipated that the modules

and case studies will be close to final
form, and will have been reviewed by the
six parties and observers. The face-toface meeting is required to address any
outstanding issues and finalise the
training material.

Proposed face-to-face
Meeting, Europe

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