Transcription of I ADDENDUM TO ICH E6(R1): GUIDELINE FOR …
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INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED GUIDELINE INTEGRATED ADDENDUM TO ICH E6(R1): GUIDELINE FOR good clinical PRACTICE E6(R2) Current Step 2 version dated 11 June 2015 At Step 2 of the ICH Process, a consensus draft text or GUIDELINE , agreed by the appropriate ICH Expert Working Group, is transmitted by the ICH Steering Committee to the regulatory authorities of the ICH regions (the European Union, Japan, the USA, Health Canada and Switzerland) for internal and external consultation, according to national or regional procedures.
1 1 INTEGRATED ADDENDUM TO ICH E6(R1): GUIDELINE FOR 2 GOOD CLINICAL PRACTICE ICH 3 E6(R2) 4 INTRODUCTION 5 Good Clinical Practice (GCP) is an international ethical and scientific quality standard for 6 designing, conducting, recording and reporting trials that involve the participation of human 7 subjects. Compliance with …
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