Webinar Topic
Computerized System Validation in Clinical Research
Webinar Date & Time
16 September 2020 from 10:00 AM to 11:30 AM (CEST)
Webinar Overview
Software is used widely in clinical trials: from managing worldwide trials to finding and scheduling patients, gathering trial data, and analyzing trial results. How is the quality of the computerized systems ensured? And how do we know the data generated by these systems is reliable and robust? Validation of software ensures that clinical data generated by these systems is done in a structured way and ensures integrity, reliability, and robustness of the generated data.
In this 1-hour webinar, you will learn why computerized systems must go through a validation process when used in clinical trials, as well as the consequences of failing to validate your systems. We will explain the requirements for validation, who is responsible and when it is necessary. Through the speaker’s experience, you will learn the why, what, and how of validation with regards to regulatory requirements.
This webinar also provides you with a walk through the process of system validation and its key deliverables. And finally, you will be shown the way to either manage the validation process of your own system or make the right considerations when selecting software for your clinical trials.
Webinar takeaways for the audience
1. Understand for which software validation is required and in which regulations requirements for validation are documented
2. Understand who is responsible for validation and what the goal of validation is
3. Know what to look for when choosing software to be used in your clinical trial
4. Understand what steps should be taken to validate your (vendors’) system
5. Be aware of the challenges in the validation process and know how to ensure a smooth process
Presenter
Marieke Meulemans
Marieke (M.A.) Meulemans, M.Sc.
CEO and Founder
GCP Central B.V.
With over 15 years of experience in the clinical research world, Marieke Meulemans founded GCP Central (www.gcpcentral.com) in 2012 and is the driving force behind the company’s powerful vision.
She is changing the face of Good Clinical Practice (GCP) training by liberating clinical research professionals and organizations to learn about rules and regulations differently, revolutionizing the boring and mandatory side of GCP training and taking it to the future.
Marieke pioneered a continuous learning focused regulatory e-learning platform that changes the way we learn about compliance in the clinical research industry.
Following her own mission to put GCP knowledge at users’ fingertips and make it a core part of everyday practice.
Attendance Fee
€ 90,- for non-EUCROF members
€ 60,- for EUCROF members
Deadline for registration
15 September 2020
How to register?
1) Go on the REGISTRATION PAGE and click on the green "REGISTER" button
2) Check your order and click on the green "CHECKOUT" button
3) Fill in all the necessary information and validate your order
Confirmation
You will receive 2 confirmation emails:
A) One from Eventbrite with your invoice
B) One from "GoToWebinar" with all the necessary information to connect the D-Day!
Questions?
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