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White Paper

Jan 2015

The RbM Consortium: 10 Burning Questions about Risk-Based Study Management

By | 2016-11-16T18:35:47+00:00 January 14, 2015|White Paper|2 Comments

Moe Alsumidaie, María Proupín-Pérez, PhD, Artem Andrianov, PhD, Beat Widler, PhD, Peter Schiemann, PhD, Johanna Schenk, MD, PhD Originally published on Applied Clinical Trials [link to the article]. Quality Risk Management (QRM), Quality by Design (QbD), Risk-based Monitoring (RbM), data driven monitoring or centralized monitoring [...]

Dec 2014

Duality of Risk-based Monitoring Definition: EMA vs FDA

By | 2016-11-16T18:35:47+00:00 December 9, 2014|White Paper|Comments Off on Duality of Risk-based Monitoring Definition: EMA vs FDA

In October 2014 at the Risk-based Monitoring conference in Copenhagen the Senior Director QA Operations of Janssen, Jan Van Parijs said: "Industry is historically heavily regulated, so as an industry we are kind of used to the fact that the authorities provide a set of [...]