Clinical Research, ICH GCP and ISO14155. An Introduction

Description
Regulatory

For the novice research professional, the clinical research field can seem both daunting and confusing. This TRIUM Training provides the high-level knowledge required for a proper understanding of the research related rules, responsibilities, interactions and jargon used. An introduction to research history and definitions, ethics, guidelines (ICH GCP – ISO14155) and regulations, clinical research in pharma, biotech and medical devices, trial roles and responsibilities will be provided in an interactive fashion.

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 certification.

Next to case studies and opportunities for discussion, various exercises will ensure learning retention and practical applications.

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 clinical trials
  • Describe the therapy development process
  • List the most important guidelines and regulations on a global scale for clinical trials
  • List the various research stakeholders and how they interact
  • Explain the main sponsor, investigator and ethics committee responsibilities as per ICH GCP (R2) and ISO14155
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.