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Dr. Ulrich Köllisch

Dr. Ulrich Köllisch

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Dr. Ulrich Köllisch
By Dr. Ulrich Köllisch
on August 27, 2021

FDA recently published its quality report for FY 2020 which presents us a very interesting collection of observations, trends, and programs. Read more about it here.

Dr. Ulrich Köllisch
By Dr. Ulrich Köllisch
on April 26, 2021

Introduction

The ICH E6 Good Clinical Practice Guideline is a cornerstone in today’s guidance for Good Clinical Practice (GCP). The guidance addresses an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. With the goal to provide a unified standard for all ICH regions to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions. As of March 2021, the newest revision R3 is in a draft state, so we took the opportunity to run down the important aspects of Data Integrity and Data Governance inside the first iteration of the ICH E6 GCP principles.