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Mercure Amsterdam City Hotel

2025年6月03日 (火) 午前 8:30 - 2025年6月04日 (水) 午後 5:00

Joan Muyskenweg 10, 1096 CJ Amsterdam, Netherlands

ICH GCP Guideline Rewrite - The Future is Now

A practical orientation course on the revision to ICH GCP as it is being implemented across the industry and academia.

Early-Bird rate for DIA Industry Members Available!

DAYS

HOURS

MINUTES

SECONDS

概要

A practical orientation course on the revision to ICH GCP as it is being implemented across the industry and academia. This is the largest update to Good Clinical Practice in over 20 years, so even seasoned professionals will benefit in learning from some of the members of the expert working group responsible for writing the document.

The course is designed to give all clinical trials professionals an understanding of the thought processes behind the revision and the expectations in terms of proportionality, risk based quality management, data governance and the use of technology in clinical trials.

The course is given by GCP experts from Regulatory Authorities and industry who truly understand the current clinical trial landscape and use their expertise to look at the application of GCP to various scenarios from trial design to reporting.

参加対象

    • Clinical Operations, including trial leads, monitors, data scientists, data managers, statisticians etc.
    • Clinical Development
    • Quality Assurance
    • Service Providers
    • Investigators
    • Ethics Committee members

 

  • In fact, anyone involved in the conduct of interventional clinical trials on investigational product.

学習目的

  • Participants will be guided in understanding:

    • the new structure of ICH E6 and the reasons for the changes that have been made
    • how to conduct clinical trials using the Quality by Design and Fitness for Purpose approaches
    • the implications of the GCP revision and how to implement the changes in a way that is appropriate to the investigational product and the trial's underlying scientific questions, potential trial participants, investigators, and sponsors and their service providers
    • the implications of the major changes compared to version R2

 

  • The overall objective of the seminar is to enable participants to make informed decisions to protect the rights, safety and well-being of trial participants and to ensure the reliability of trial results, and to understand what sponsor and investigator oversight means in practice.
  • They will also learn to think cross-functionally and consider how actions affect other parties involved in conducting clinical trials.

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