Transcription of ADDENDUM TO ICH E11: CLINICAL INVESTIGATION …
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ADDENDUM TO ICH E11: CLINICAL INVESTIGATION …
INTERNATIONAL COUNCIL ON HARMONISATION OF TECHNICAL. REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE. ICH HARMONISED GUIDELINE. ADDENDUM to ich e11 : CLINICAL INVESTIGATION OF. medicinal PRODUCTS IN THE PEDIATRIC. POPULATION. E11 (R1). Current Step 4 version dated 20 July 2017. This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the ICH regulatory bodies. i ICH E11(R1).
3 ICH HARMONISED GUIDELINE ADDENDUM TO ICH E11: CLINICAL INVESTIGATION OF MEDICINAL PRODUCTS IN THE PEDIATRIC POPULATION E11 (R1) ICH Consensus Guideline Released for Adoption on 18 August 2017, at Step 4 of the ICH
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