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Konferenz

ICH E6 GCP (R3) Update Course

The new international guideline for conducting clinical trials:          effective as of 23July25.​

Referentin Heidrun Beckert

Your trainer:

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Heidrun Beckert 

Clinical Monitoring & Consulting Services

GCP Expert & Trainer   

> 20  years of experience in the field of clinical project management and monitoring                                   

Registration

Many thanks for your registration. You will receive a confirmation via email soon.

In case of any technical registration issues, please contact us at: info@medics-gcp.com

Target group: for all team members of investigational sites in clinical studies, the research industry (Sponsor, CRO, other service providers), as well as for GCP auditors and GCP inspectors of competent authorties.

 

​Participation Fee: 340,00 € (plus 19% tax for foreign private persons; for foreign institutions, reverse charge process is valid)

Please use our booking template for registration purposes.

Last minute registration is possible.

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​You will receive your attendance certificate after the succesfull completion of the evaluation test.              

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Duration: Online (MS Teams)                                     09.00 a.m.- 1 p.m.

CEST: Central European Summer Time (UTC+2)

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Dates: 

Friday, 30. January 2026

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This training course is also availabe as an independent in-house online webinar.

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Agenda​

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The renovated ICH E6 GCP R3 guideline: 

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  • main reasons and goals for the renovation

  • scope of validity and timelines

  • new structure 

  • the influence of guideline E8 (R1): general considerations for clinical trials

  • the new 11 principles: new keywords and their meaning "fit for purpose/ quality by design/ critical to quality factors"

  • Annex 1

    • Responsibilities of the independent ethic committees

    • Investigator: new options through decentralization/ focus oversight

    • Sponsor: influence of the new principles to the quality management system/ focus oversight

    • Data Governance: new responsibilities for Sponsors and Investigators in the data handling process

    • Appendices A- C: Investigator Brochure, study Protocol and Essential Records

  • Annex 2: more flexibility for different study designs

  • Declaration of Helsinki: Update 2024 for the ethical guideline

  • Conclusion: what is really new and how should this be implemented adequately?

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