ICH GCP R3 is now in English & EU languages. Book Now
  • Clinical PracticeClinical PracticeRight Arrow
  • PharmacovigilancePharmacovigilanceRight Arrow
  • ManufacturingManufacturingRight Arrow
  • Laboratory PracticeLaboratory PracticeRight Arrow
  • DistributionDistributionRight Arrow
Clinical Practice
Pharmacovigilance
Manufacturing
Laboratory Practice
Distribution

Course Syllabus

  1. Purpose of the refresher, evolution of GCP, and objectives of the R3 revision

  1. Structural changes, overarching principles, and the move toward flexible, risk-based frameworks

  1. Ethical conduct, participant safety, data reliability, and Quality by Design fundamentals

  1. Critical to Quality factors, QTLs, and proactive risk oversight through the trial lifecycle

  1. Oversight in decentralized settings, delegation, consent processes, and safety reporting

  1. Quality Management Systems (QMS), CRO oversight, monitoring strategies, and data control

  1. ALCOA+ principles, validation of electronic systems, remote data handling, and archiving

  1. Strengthened IEC/IRB roles, continuous ethical review, and modern consent approaches

  1. Essential documents, version control, and secure archiving of trial records

  1. Recap of key changes, implementation checklist, and final knowledge quiz

Our GCP certified customers

ICH E6(R3) introduces modernized principles reflecting today’s clinical trial landscape — including decentralized and hybrid studies, digital data collection, and proportionate quality oversight. This course highlights the key changes from R2 to R3, emphasizing Quality by Design, Risk-Based Quality Management, and the strengthened roles of investigators, sponsors, and ethics committees.

  • The key updates and structure of ICH GCP E6(R3)
  • How to apply Quality by Design and Critical to Quality concepts
  • The fundamentals of risk-based and proportionate monitoring
  • Updated expectations for data integrity and digital systems
  • Enhanced ethical requirements for participant protection and informed consent

This course is designed for professionals who have previously completed full ICH GCP (E6 R2) training and now need a concise refresher on thelatest updates introduced in E6 (R3).
It’s ideal for:

  • Clinical researchers, investigators, and site staff who want to stay current with evolving GCP standards
  • Sponsor and CRO teams seeking a quick update on R3-specific changes
  • Quality assurance, regulatory, and compliance professionals maintaining ongoing certification
  • Experienced GCP learners who prefer a focused, 2-hour update rather than a full certification course.

This GCP Refresher Course is globally accepted and widely recognised by leading pharmaceutical sponsors, biotechnology companies, and Contract Research Organisations (CROs).