Upcoming Events

There are no upcoming events at this time.

Register Today!

Get Free Test Access

ICH Goes Risk-Based

ICH GCP Goes Risk-Based

GCP Addendum Review and Embracement Plan

by Artem Andrianov, PhD, Beat Widler, PhD, Maria Proupín-Pérez, PhD
Web-View

AppliedClinicalTrials, May 2015: The new upcoming GCP E6 (R2) addendum has the potential to reform clinical monitoring and clinical trial management. What changes does it bring to all of us? What does this mean for a pharmaceutical company, for a Contract Research Organization (CRO) and for an investigator in terms of changes to the processes of trial oversight, data collection and reporting and trial design and planning? In this article, you will find a structured summary and critical review of the new addendum, and as well as ideas on how to prepare for these regulatory changes.

By | 2016-11-16T18:35:45+00:00 May 26, 2015|Library|0 Comments

About the Author:

Professional in the integration of data-driven Risk-based Monitoring (RbM) process in international clinical trials of pharmacology. Speaker at regional and global conferences such as: DIA, PharmaForum, PharmaDay, DGGF, etc. 10+ years of experience in data quality projects and biostatistics for the pharmaceutical industry. Life passion: improving clinical research with RbM, driving the RbM research to new frontiers for CROs, pharma and biotech companies.

Leave A Comment