Module 3 - Strategic case studies in practice

Q8(R2) Document History

First Codification

History

Date

Parent Guideline: Pharmaceutical Development

Q8

Approval of the Guideline by the Steering Committee under Step 2 and release for public consultation.

18 November 2004 10 November 2005 1 November 2007 13 November 2008

Q8

Approval of the Guideline by the Steering Committee under Step 4 and recommendation for adoption to the three ICH regulatory bodies.

Annex to the Parent Guideline: Pharmaceutical Development

Annex to Q8 Approval of the Annex by the Steering Committee under Step 2 and release for public consultation.

Annex to Q8 Approval of the Annex by the Steering Committee under Step 4 and recommendation for adoption to the three ICH regulatory bodies.

Addition of Annex to the Parent Guideline

Q8(R1)

The parent guideline “Pharmaceutical Development” was recoded Q8(R1) following the addition of the Annex to the parent guideline.

November 2008

Current Step 4 version

Q8(R2)

Corrigendum to titles of “Figure 2a” and “Figure 2b” of “Example 2” on page 23.

August 2009