ICH GCP E6 R2 and ISO 14155: a refresher to avoid audit or inspection findings (Classroom 24 Nov 2020)

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.

TRIUM reference: T0358

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
Training design
Classroom Training
Training duration
4 hour
Training Language
English
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
Isabelle De Bock
Isabelle De Bock has almost 17 years of clinical research experience in the medical device industry. While she started as an international CRA, Isabelle held many other roles and responsibilities within the clinical landscape varying from project lead and clinical manager to compliance manager responsible for SOP maintenance, training, audit support & inspection readiness. Prior to joining TRIUM in September 2019 as Manager Operations, Isabelle was a dedicated supervisor for about 5 years, managing an international group of monitors and building up from scratch an in-house CRA team, having line management responsibilities for more than 15 employees at once.  Isabelle is used to work in a global environment across different departments & multiple regions around the globe. She holds a master degree in Biology, did 2 years of PhD scholarship at the University of Leuven and obtained a Teacher Degree as well prior to joining the clinical research world.