ICH GCP E6 (R2). Build your Own Flexible Clinical Quality Management System (QMS).

Description
Quality

Not sure how to start building your QMS? This TRIUM Session will get you started the good way. Setting up a QMS is not a task done in a silo, collaborations on different organizational levels are needed to succeed. This Session provides enough information to ensure buy-in from the different stakeholders involved and an overview of the tools needed to setup and maintain such QMS specifically for clinical trials, giving you the starting point you need for compliance.

At the end, you will receive a certificate and handy hand-outs for later use.

Learning objectives

By the end of this TRIUM Training you should be able to:

  • Define Quality Management Systems
  • Identify the different stakeholders
  • Describe the foundational aspects of the setup and maintenance of a clinical QMS
Intended audience

Fundamental Level
Can perform the task and/or exhibit the knowledge at an essential or foundational level. May require some coaching or supervision.

Trainer
Esther Daemen
Esther Daemen is currently ‘Quality &Training Director – Data Protection manager’ at TRIUM Clinical Consulting and has over 27 years of working experience in the healthcare/pharma & device field. She served many organizations in different research roles and as professional development director at ACRP global. She gained a bachelor’s in nursing and earned project management, training and DPO certificates as well as and a master´s degree in Business. Esther is also a highly sought-after presenter at professional conferences/universities and a writer of peer-reviewed articles for professional magazines like ‘The Clinical Researcher’. Her work was rewarded by the KP Morgan 'OECT Summit 10Years Speaker Achievement Award' in 2020, the ‘Best trainer to watch’ 2010 Training Magazine award and by having her organization ‘Kendle’ being listed as one of the top 125 training providers in the world in 2008. "TRIUM is an expert Contract Research Organization that offers a unique combination of global CRO services, staffing solutions, quality services, GDPR consultancy and risk-based approaches as well as training services. It’s our mission to be a passionate, dedicated business partner with a focus on excellence to provide start‐to‐finish clinical trial activities tailored to the timing, budget and specific needs of the Sponsor.”