Navigating the New Data Governance Section of ICH E6(R3)

Data governance - ensuring reliable data in clinical trials

Are you a Clinical Trial Professional involved in activities under the responsibility of the Sponsor, Service Provider or Investigator?

Join us for this insightful webinar as we explore the new data governance section in Good Clinical Practice (GCP) guidelines and discuss what these updated requirements mean for your role.

Webinar details:

📅 Date: 2025-09-04
🕒 Time: 12.00-12.30 CET
📍 Location: Online (link provided upon registration)

Agenda:

✅ Foundations of Data Governance in Clinical Research
✅ Principle 9 of ICH E6(R3)
✅ Key Processes and the Data Life Cycle
✅ Ensuring Systems Are Fit for Purpose

This webinar provides an overview of data governance, data integrity, and the ALCOA+ principles. It includes an examination of Principle 9 of ICH E6(R3), highlighting its pivotal role in establishing robust data governance frameworks. We will also explore key processes across the entire data life cycle—from data collection to archiving—as well as the criteria and best practices for implementing and maintaining compliant computerized systems in clinical trials.

This webinar is essential for professionals involved in clinical trials, including those working in Clinical Development, Clinical Operations, Quality Assurance, and Biometrics—such as data managers, data scientists, statisticians, and statistical programmers.

Speakers:
Louise Kvistgaard, Senior QA Consultant GCP and GCP Lead Auditor, louise.kvistgaard@pharmarelations.se
Helena Risinggård, Senior QA Consultant GCP,
helena.risinggard@pharmarelations.se
Katarina Grip, Senior Consultant QA IT Regulatory Service
katarina.grip@pharmarelations.se

Soon you will be able to register.