Transition of clinical trials from CTD to the legal framework of the CTR

Transition of Clinical Trials from the Regime of the CTD
to the Legal Framework of the CTR - There Is No Time to Lose

Date & Time: 04 June 2024 from 03:00 PM to 04:30 PM (CEST)

Overview
All clinical trials that will not be finished in the EU/EEA until the end of the transition period (30 January 2025) need to transit from the EU Directive 2001/20/EC (CTD) to the EU Regulation 536/2014 (CTR). Until 30 January 2025, the transition must be submitted, validated, assessed, and authorised, otherwise the clinical trial is being conducted without authorisation which is considered non-compliant under current law.
As the deadline is fast approaching, all sponsors are requested to submit their transition trials on time and as soon as possible. But what does on time mean? How is the procedure working? What do sponsors have to do as a minimum not to end up without authorisations for their clinical trials? And – are there any country specifics sponsors must know?
In this EUCROF Webinar, the regulatory background for the transition of clinical trials from one legal framework into the other will be presented. In addition, the new transparency rules will be briefly touched in the context of transition trials. You will be informed about the ins and outs of the transition process by numerous practical examples and you will learn “what is good to know” to facilitate the entire process.
Don’t miss this EUCROF Webinar – you will certainly benefit from it for your transition trials.

Presenters:

Dr. Dagmar Chase

Dagmar Chase graduated in Computer Science with a secondary focus on Theoretical Medicine from the Technical University in Munich and gained a PhD in Human Biology from the Medical Faculty of the University in Ulm, Germany. Dagmar Chase co-founded the company GMI, a full service CRO for clinical trials phase II – IV, in 1983. Besides developing GMI into one of the largest CROs in Germany, she concentrated on Quality Management as well as the development of training programs for the pharmaceutical industry. After the merger of GMI with the US-based CRO Kendle International Inc in 1997 (now Syneos Health), she held the position of vice president until the beginning of 2004. In March 2004, Dagmar Chase started up Clinrex, a consultancy firm for clinical research. Dagmar Chase is a co-founder of the German CRO association BVMA e.V. which was established in 1991. She was president of the BVMA from 2001 until the end of 2017. Dr. Chase is also a co-founder of EUCROF, the European CRO Federation, and held the position of vice-president for 10 years until the end of 2016.

Dr. Iris Romero Matuschek

Iris Romero Matuschek holds a PhD degree in Biochemistry from the Johann-Wolfgang-Goethe University Frankfurt for research on cell nucleus export mechanisms. Since 2001, she works in the Pharmaceutical Industry. Worked for 12 years at Theorem Clinical Research (former Omnicare Clinical Research) as CRA, Clinical Trial Manager and as Senior Clinical Service Manager International being responsible for clinical trial submissions to regulatory authorities by leading the International Clinical Services Center in Europe. Since 2012, Iris Romoero Matuschek is with ICON Clinical Research (formerly PRA) in the Regulatory Department of the DACH region and since 2015, I am leading the Systems-Subgroup in the EU CTR Initiative. In this role, she participated in CTIS User Acceptance Testings and am ICONs CTR Country Consultant and CTIS Sponsor Master Trainer. In addition to presentations at the DGPharMed and the BVMA, she co-authored with Dagmar Chase and Beate Roder a BVMA publication about CTR and CTIS in the Bundesgesundheitsblatt in January 2023 and published two further articles in TOPRAs Regulatory Rapporteur in March 2021 and June 2023.

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Host or Publisher EUCROF