ICH GCP E6 R2 and ISO14155

Description
Regulatory

After having received your first ICH GCP E6 and/or ISO 14155 training, it is a custom in the research field to repeat this training on a frequent basis to ensure compliance and to avoid QA findings and the unwanted related subject safety/well-being and data quality’ issues at all times. This TRIUM Training provides the in-depth knowledge and skills required for a proper understanding and application of the ICH GCP E6 R2 guideline- and ISO 14155 standard principles in the research field. Each section for both ICH GCP E6 R2 and ISO 14155 will be covered in theory, followed by interactive discussions, sharing of real life case studies and exercises showing how the requirements and responsibilities of the roles described (sponsor, investigator, IEC/IRB e.g.) intertwine. The provided gap analysis between ICH GCP E6 R2  and ISO 14155 helps researcher who work or both drug/bio- and device studies or on combination products to know the difference and to ensure quality for both.

For both the junior and experienced research professional, this is the ideal training to refresh and update your ICH GCP R2 and ISO 14155 knowledge and certificate. This training is certified by Transcelerate.

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:

  • Describe the ICH GCP E6 R2 and ISO 14155 principles
  • Explain the responsibilities of the investigator, sponsor and Ethics Committee for ICH GCP E6 R2 and ISO 14155
  • List the purpose and content of a trial protocol/clinical investigation plan and the Investigator Brochure (IB)
  • Describe the purpose and the requirements related to essential documents for the conduct of a clinical trial
  • Apply what you learned to your daily research practice to ensure subject well-being and data quality
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.”