ICH GCP E6 (R2). Vendor Oversight that Works.

Description
Operational

As a sponsor or investigational site you are required to ensure oversight of the vendors you work with to ensure qualitative and safe clinical trials.

A vendor oversight program should be structured, adaptable, and repeatable across multiple vendors and clinical trials and programs. In this TRIUM Session, you will learn to list the different key components of an effective vendor oversight model, offering you a head-start in the development of your own model.

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 Vendor Oversight
  • Describe the elements of an effective vendor oversight model
  • Create meaningful quality and operational metrics
Intended audience

Skilled Level
Can perform task or skill independently, consistently, accurately, and has a moderate level of expertise. Efficient and high quality work. Able to independently navigate resources and uses tools well.

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.”