Introduction to Good Clinical Practices (Recorded session)

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.

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
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.”