ICH GCP E6 (R2) Recordings

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
  • Define electronical systems; List what elements need to be outlined in a validation SOP
  • Define Vendor Oversight; Describe the elements of an effective vendor oversight model; Create meaningful quality and operational metrics
  • Define RCA and CAPA; Describe the different RCA and CAPA methodologies
  • Define risks, risk-based monitoring techniques and plans; Describe the steps involved in conducting risk assessments
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.

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.”