ICH GCP E6 (R3) - Important Updates

ICH GCP E6 (R3) – Important Updates

Supplementary training to ICH GCP E6 (R2)

$43.00

Scroll down to the tab below Description of the course to see if you are eligible to do this course FOR FREE

This course is for all clinical research professionals and stakeholders (CRO’s, Biopharmaceuticals, Sponsors,  Clinical Research Sites & Ethics Committees) around the globe who has a current valid ICH GCP E6 (R2) certification.

The review of the ICH GCP E6 (R3) guidelines has reached Step 4, with the final version adopted on 06 January 2025, which means the guideline is now considered complete and is endorsed by the ICH Assembly.

This also means that the member regulatory authorities of ICH (such as the FDA, EMA, PMDA, etc.) have formally adopted the guideline into their respective regulatory frameworks, which means the guideline is now part of the official regulatory requirements in these regions and should be followed by all stakeholders and individuals conducting clinical trials or working in drug development.

The course has been designed by industry experts to ensure you stay up to date with the latest regulations to conduct high quality clinical trials. The ICH GCP E6 (R3) course is designed to help you digest the extensive updates made, by taking you through each section step-by-step. See below for more information on the course.

Enrol now to stay compliant!

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Description

In the ICH GCP E6 (R3) Updates course you will learn about:

  • The new layout of ICH GCP
  • Updates made to the IRB / IEC section
  • Updates made to the Investigator section
  • Updates made to the Sponsor section
  • NEW section on Data Governance
  • Updates made to Essential Records
  • Updates to the Glossary : New and updated terminologies

This course is:

  • A supplementary course to current GCP (R2) certificate holders
  • 100% online
  • Developed by industry for industry
  • Self-paced modules, stop and start as it fits your schedule
  • About 2 hours just tackling the updates made to R2
  • Rich and immersive learning content
  • Shareable certificate on completion of an online assessment

Eligible to do the course for free?

  • If you acquired your ICH GCP (R2) training (beginners or refresher) from TRA in 2025 you will be able to enrol FOR FREE. Contact academy@task.org.za
  • If you are planning to enrol for first time ICH and/or SA GCP beginners OR refresher course with TRA you will receive this supplementary course FOR FREE. When you register with us for beginners or refresher GCP training you will be automatically enrolled to the R3 updates course FOR FREE.
  • If you acquired your ICH GCP (R2) training (beginners or refresher) before 2025 you will need to register and pay for the supplementary course
  • Remember organisations– for every 5 registrations, you get ONE FREE seat!

Pre-requisites

This is a supplementary course, not a full first-time beginner GCP course, nor a full GCP refresher course. This is a course ONLY training current GCP certified professionals on the updates made from ICH GCP E6 (R2) to (R3).

You must be in the possession of a current valid ICH GCP (R2) training certificate as you will not receive a valid GCP certification, only a certificate that informs you attended to training on the latest ICH GCP E6 (R3) updates.

Who should attend this course?

  • Individuals with a current valid ICH GCP E6 (R2) certificate working in the industry, like Clinical trial assistants (CTAs), Clinical research nurses (CRNs), Clinical Study Coordinators, Investigators, Research Pharmacists, CRA’s, Central Monitors, Data capturers, Data Managers, Statisticians, Project Managers, Regulatory Specialists, Quality Assurance staff, Internal monitors, Clinical Laboratory Staff, Recruiters,  Members of a community advisory board (CAB), Pharmacovigilance staff, Ethics committee members, Auditors, GCP training providers etc.

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