Transcription of Addendum to ICH E6 (R2)
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Addendum to ICH E6 (R2)
11/23/201511 Addendum to ICH E6 (R2)Stephanie Shapley (US FDA) -RapporteurDr. Fergus Sweeney (EMA) -Regulatory ChairDate:December15, 2015 International Council for Harmonisationof Technical Requirementsfor Pharmaceuticals for Human UseLegal NoticeThis presentation is protected by copyright and may be used, reproduced, incorporated into other works, adapted, modified, translated or distributed under a public license provided that ICH's copyright in the presentation is acknowledged at all times. In case of any adaption, modification or translation of the presentation, reasonable steps must be taken to clearly label, demarcate or otherwise identify that changes were made to or based on the original presentation. Any impression that the adaption, modification or translation of the original presentation is endorsed or sponsored by the ICH must be avoided.
11/23/2015 4 2. Addendum Objective 7 ICH E6: Integrated Addendum: Good Clinical Practice • This guideline has been amended to encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight,
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