ICH E6(R2) EWG Work Plan
15 August 2014
Topic Adopted: 15 April 2014
Last Face-to-Face Meeting: Minneapolis, MN, USA – June 2014
1. Anticipated Milestones
Completion Date
Deliverable
March 2015
Step 1 Technical Document
June 2015
Step 2a Technical Document
June 2015
Step 2b Draft Guideline
June 2016
Step 3 Expert draft Guideline
November 2016
Step 4 Final Guideline
2. Timelines
Date
Task / Activity
Details
June 2014
Face to face meeting
 Finalize Business Plan and Concept
Paper
 Begin developing the content of the
Addendum
July 2014 October 2014
Webconferences every 3
weeks
 Developing the content of the
addendum
 Consulting and outreach (e.g.,
briefings, webconferences) within our
regions and resolving feedback
received within the regions
November 2014 Face to face meeting
 Discuss any unresolved issues
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