The Joys and Challenges of the New EMA Guideline on Computerised Systems
The Joys and Challenges of the New EMA Guideline on Computerised Systems
Date and time
Location
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About this event
The Joys and Challenges of the New EMA Guideline on Computerised Systems
Date & Time: 23 May 2024 from 10:00 to 11:00 (CEST)
Overview
This webinar provides a short introduction into the “Guideline on computerised systems and electronic data in clinical trials”. It will show how the authorities want to ensure data integrity. The presentation will cover the three levels of the guideline from data flow diagrams to the different annexes. Not all details can be presented in the webinar, but it will highlight the new expectations of the EMA, some of which are helpful and some present challenges. There are no one-solution-fits-all answers, but some points and ideas to consider for your organization should emerge from the webinar.
Presenter:
Marc E. Brooks
CEO
Elderbrook Consulting GmbH
Dr. Brooks has more than 20 years experience in IT, Quality, and Security. He worked for a consulting company in the mobile phone industry as database and middleware administrator. He also had the role as project quality manager during this time for ISO9000 compliant projects.
In 2003 he moved on into the pharmaceutical industry as validation manager being responsible for the compliance of all computerized systems globally used in clinical development. He has been working for a syringe manufacturing company and a start-up developing a fraud protection solution. In 2008, he started a consultancy for computer systems validation, focusing on clinical development but also working in the preclinical and manufacturing area. The past ten years he has mainly performed audits, but also provides validation, consulting, interim management, and training services.
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