Hot Topic Seminar: Electronic Systems and Data Integrity in GCP

Are you updated on requirements and frequent deviations on electronic systems in clinical trials?

  • 18. Dec 2018

1 day course

English

2.500,- DKK ex VAT
(app. 336,- EUR ex VAT)

This seminar is from 14.00 to 17.00.

Summary

Get a brief update on requirements on eSystems and eData including those from the revised ICH-GCP-guideline and the upcoming European eGuidance from the GCP Inspectors Working Group and see selected inspection deviations related to electronic systems.

The use of electronic systems in clinical trials has continued to expand enormously, with most trials now incorporating multiple electronic systems. Initially, this was primarily for case report forms, but other areas of the trial conduct have been subject to computerization as well. This has expanded significantly with the development of e.g. mobile devices and web-based systems.

The requirements of Good Clinical Practice are in place to ensure both the integrity of the information/data generated during a clinical trial and the reconstruction of the trial conduct that are equally applicable to electronic systems and processes. The EMA Reflection Paper began to address these areas when it was published in 2010, however, the development and experience of such systems has progressed, and updated guidance is on its way. The European GCP Inspectors continue to identify significant inspection deviations in this area, which can cause e.g. lack of or postponed approvals of marketing authorizations or withdrawals or corrections of publications.

In this hot topic seminar you will be updated on current and upcoming requirements on eSystems and eData in clinical trials by a Danish Medicines Inspector. We will discuss the principles of data integrity specific to GCP and you will be presented to selected deviations from GCP inspections related to the use of electronic systems.

In addition, you will have the possibility to network and exchange experiences with collaborators from a wide variety of academia, CROs and pharma companies.

This hot topic seminar is the second out of two seminars focusing on data integrity. On 29 November 2018, we looked into the broad perspective of data integrity in GxP. Click here to read more

Keywords

GCP – Good Clinical Practice
Data Integrity
Electronic systems and data
Inspection findings and deviations
New Guidance

What you will learn

  1. What the current requirements on electronic systems and data are
  2. What the typical IT inspection findings are
  3. How you minimize the risk of significant inspection deviations in relation to data integrity issues with electronic systems

What your company will get

  1. A professional who is updated and knows the essence of current requirements on electronic systems and data
  2. A professional who understands the potential inspection findings and knows how to minimise the risk of significant inspection deviations in relation to data integrity issues with electronic systems
  3. A professional who, with respect to current requirements on electronic systems and data, can provide valuable input to all other team members
Available start dates
18. Dec 2018 (Registration deadline expired)

Registration quick facts

You can pay by credit card or by invoice. We charge the amount shortly after you register. If you cancel your registration more than 30 days prior to the course, you will receive a full refund. Read our cancellation policy.

Yes, if you experience any technical problems, please call us at + 45 39 27 60 60, or send us an email at contact@atriumcph.com

If you cancel your registration more than 30 days prior to the course, you will receive a full refund. If you get sick on the day of the course, you can hand over your seat to a colleague. To hand over your seat, please contact us at +45 39 27 60 60. Read our cancellation policy.

WANT TO KNOW MORE ABOUT THIS COURSE?

Contact Programme Director Gitte Hornemann Møller at +45 39 15 09 20

Send an email

 

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