EU Clinical Trial Regulation

Description
Regulatory

The EU Clinical Trial Regulation 536/2014 is ready and it’s anticipated that it will become law in the member states as of November 2018, replacing the ‘GCP’ Directive 2005/28/EC. ISO 14155, the ‘GCP’ for medical device trials will be updated by 2019.

This live online TRIUM Session will provide an update of the expected changes and how they will affect pharma and medical device trials.

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

Learning objectives

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

  • Describe the differences between the EU ‘GCP directives’ and the EU Clinical Trial Regulation 536/2014
  • List the expected changes to the ISO 14155 standard
  • Describe how these changes affect your role in clinical research
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.”