13 July 2022 - EMA Clinical Trials Information System (CTIS) CRO / Sponsor Organization Models in CTIS

Webinar Topic

EMA Clinical Trials Information System (CTIS) CRO / Sponsor Organization Models in CTIS

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Webinar Date & Time

13 July from 03:00 PM to 04:30 PM (CEST)

 

Webinar Overview

As of January 31st, 2022 all research on human subjects with medicinal products in the EU need to be submitted via the EMA Clinical Trial Information System, the CTIS. In the current transition period, organizations focus on the setup of the optimal organisation model in CTIS, which ensures a smooth collaboration between CROs and Sponsors and enables optimal use of the standardized timelines of EU CTR.

 

In this Webinar, Marieke Meulemans explores the possible organisation models and discusses different scenarios around this topic. An organisation-centric model with a Sponsor Admin overseeing assignment of Clinical Trial Admins seems to be the most logical execution model for most of the (big) CROs and Sponsors. What is the best organisation model for small and mid-sized CROs? How will access be granted to CROs? And what Organisation model to propose to your Sponsor in a multi-CRO model? The sponsor would probably want to restrict access, without impacting the collaboration. Attending this webinar makes you aware of the possible organisation models in CTIS and what scenarios CROs can propose to their clients.

 


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Presenters

Marieke Meulemans

CEO and Founder

GCP Central B.V.


Founder and CEO of regulatory training company GCP Central 
Master’s degree in Health Sciences, and 20 years of experience in the life science industry, including her work for top 50 Pharma companies, CROs and training academic hospitals in clinical research, 
Was member of the CTIS Training Expert Group of EMA, validating EMA’s CTIS training from the perspective of Industry Sponsors
Has created an online EU CTR training together with 70 experts, translating the EU CTR to clinical practice and is part of the Dutch EU CTR Implementation Steering Group
Involved in training both Sites and Sponsors in the implementation of the CTR and the use of the CTIS, as it is Marieke’s mission to make regulatory knowledge a core part of everyday practice and improving the quality of research. 
Member of the EUCROF Events and Training Working Group

https://www.linkedin.com/in/mariekemeulemans/
https://gcpcentral.com/
https://gcpcentral.com/press-and-speaking/


 

Attendance Fee

€ 90,- for non-EUCROF members

€ 60,- for EUCROF members

 

Deadline for registration

12 July 2022

 

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