ICH E6 (R3) for Medical Writers

Categories: Medical writing
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About course

This training is designed to help medical writing professionals to become familiar with the ICH E6 R3 guideline. The learning objectives of this training are:

1) understand and interpret the ICH E6 (R3) guideline,

2) evaluate its impact on medical writing, and

3) identify changes needed to trial-related documents.

What will you learn?

  • Chapter 1 Overview of ICH E6 (R3): The ICH Guideline E6 R3 became effective in the EU on 23 July 2025, and in the US in September 2025. The new guideline has undergone a major restructuring and continued modernization. An overview of the ICH E6 R3 is provided in this chapter.
  • Chapter 2 Principles of ICH GCP: In this chapter, we will go over the principles of ICH GCP in more detail and reflect their impact on our work as medical writer.
  • Chapter 3 Annex: In this chapter, we will briefly discuss Annex 1 of the revised guideline from a medical writing point of view.
  • Chapter 4 Appendices A, B, C: In this chapter, the appendices to Annex 1 are discussed. These appendices detail what is to be expected in the Investigator’s Brochures, Clinical Trial Protocols and Protocol Amendments, and Essential Records for the Conduct of a Clinical Trial.  All important changes compared to R2 are also discussed in more detail.
  • Chapter 5 Glossery: In this chapter, we will have a closer look at the Glossary.
  • Chapter 6 Summary: This final chapter highlights the main points that have been discussed in previous chapters and summarizes the impact on medical writing and on the content of clinical trial-related documents.

Course content

ICH E6 (R3) for Medical Writers
This training is designed to help medical writing professionals to become familiar with the ICH E6 R3 guideline. The learning objectives of this training are: 1) understand and interpret the ICH E6 (R3) guideline, 2) evaluate its impact on medical writing, and 3) identify changes needed to trial-related documents.

  • Introduction about ICH E6 (R3) for Medical Writers
    01:30
  • Overview of ICH E6 (R3)
    06:44
  • Principles of ICH GCP
    11:57
  • Annex 1
    16:46
  • Appendices A, B, C
    13:46
  • Glossary
    02:14
  • Summary
    03:15
  • Congratulations
    00:21

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A course by

Thary Jacob
Thary Jacob

Currently, I’m a motivated specialist medial writer at Emtex Life Science.

I studied biomedical sciences at the University of Ghent, mastered in immunology and did a PhD at the laboratory for veterinary animal sciences in Merelbeke on alphaherpesviral spread, triggered by interesting research along my path.

While I enjoyed doing this, I wanted to be closer to patients in my career path, which is why I chose to go to the industry. I wanted to be near the end, the patient, the finalized stage - to contribute to telling the story. Medical writer seemed the perfect job for me, and I haven’t had any regrets during the past 8 years that I’m a medical writer at Emtex.

Emtex offers worldwide professional medical writing and related services to the pharmaceutical (human & veterinary), biotech, medical device and other industries, CROs and academic institutions.

With over 20 years of experience in the field, we guarantee the best possible medical writing and related services.