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ICH HARMONISED GUIDELINE

INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL. REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE (ICH). ICH HARMONISED GUIDELINE . INTEGRATED ADDENDUM TO ICH E6(R1): GUIDELINE FOR GOOD clinical PRACTICE. E6(R2). Current Step 4 version dated 9 November 2016. E6(R1). Document History New First Codification History Date Codification November 2005. E6 Approval by the Steering Committee under Step 2 27 E6. and release for public consultation. April 1995. E6 Approval by the Steering Committee under Step 4 1 E6. and recommended for adoption to the three ICH May regulatory bodies. 1996. E6(R1) Step 4 version E6 Approval by the Steering Committee of Post-Step 4 10 E6(R1). editorial corrections. June 1996. Current E6(R2) Addendum Step 4 version Code History Date E6(R2) Adoption by the Regulatory Members of the ICH Assembly 9 November under Step 4.

i ich harmonised guideline integrated addendum to ich e6(r1): guideline for good clinical practice ich e6(r2) ich consensus guideline table of contents introduction..... 1

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