Webinar Topic
EU CTR and CTIS: Getting the most out of it
Webinar Date & Time
21 March from 03:00 PM to 04:30 PM (CET)
Webinar Overview
As of January 31st, 2023 all research on human subjects with medicinal products in the EU needs to be submitted via the EMA Clinical Trial Information System, the CTIS. Up to now, in the current transition period, organizations focussed on the setup of the optimal organization model in CTIS, and the preparation for their first submissions via the system.
In this Webinar, Marieke Meulemans and John Popp explore and share the “lessons learned” from the first year of the transition: the challenges, the most common mistakes, and how to solve them. We will discuss transition strategies, look at the opportunities of EU CTR and CTIS and how to get the most out of it for your organization. Regardless of whether you are working for a CRO, pharma company or biotech, the EU CTR is an opportunity to streamline, automate and improve processes to remain efficient, while complying with legal responsibilities.
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/
John Popp
Senior Consultant, Life Science & Healthcare
Deloitte Netherlands – Risk Advisory
John is a consultant in the life science & healthcare team within Deloitte Netherlands focusing on the regulatory aspect of clinical trials. Over the last years, John has supported several international pharmaceutical companies defining and executing optimal strategies for CTR implementation and clinical trial management through CTIS. Prior to that, John has spent 10 years in academic research, as a result of which he holds a PhD in chemistry.
https://www.linkedin.com/in/john-popp/
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Attendance Fee
€ 90,- for non-EUCROF members
€ 60,- for EUCROF members
Deadline for registration
20 March 2023
How to register?
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3) Fill in all the necessary information and validate your order
Confirmation
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Questions?
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