ISO 14155 2020 (Live Online)

Description
Operational

The updated ISO 14155 guideline published in 2020 provides guidance and requirements on how clinical trials should be conducted.

This 3-hour course will focus on the impact of the new ISO 14155:2020 on clinical investigations and our daily work in clinical research. Emphasis lies on the roles and responsibilities, how this version differs from the previous one and from GCP E6 R2, and how it relates to the MDR.

At the end, attendees will receive a certificate and the course hand-outs (in PDF format).

Learning objectives

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

  • Identify the main changes from the 2011 ISO 14155 version
  • Explain the sponsor, IEC and investigator responsibilities per ISO 14155:2020
  • Explain the differences and similarities between ICH GCP E6 R2,MDR and ISO 14155:2020
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 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.”