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Documents Conducting Studies to the International Gold Standard: Going Beyond What the FDA Requires

1. Presented byPaul Below, CCRA, CCRT P. Below Consulting, Inc. Conducting Studies to theInternational Gold StandardGoing Beyond What the FDA Requires 2. Learning Objectives•…

Documents ICH Harmonised Tripartite Guideline for Good Clinical Practice Part I (Principles, IRB/IEC,...

Slide 1ICH Harmonised Tripartite Guideline for Good Clinical Practice Part I (Principles, IRB/IEC, Investigator, Sponsor) Josip Arlica, MD Altiora Training Program “Train…

Documents The Importance of Standard Operating Procedures (SOPs) in ...

1. The Importance of Standard Operating Procedures (SOPs) in Clinical Trials 2. The Main Objective: • Be a GREAT clinical research site – For the sponsor…

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Curso GCP - GCP1: Overview of ICH GCP Welcome The International Conference on Harmonisation (ICH) Good Clinical Practice Guideline (E6) contains the essential building blocks…

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SPRI Ukraine Domestic CRO with Professional and Cultural Experience www.spriukraine.com Overview Introduction SPRI Ukraine Structure SPRI Ukraine Advantages Regulatory Affairs…

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1. INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICALREQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMANUSE ICH HARMONISED TRIPARTITE GUIDELINE GUIDELINE FOR GOOD…