Webinar Topic
EU Clinical Trial Regulation 536/2014 (CTR): Transitional Provisions and New Concepts
Webinar Date & Time
30 March from 10:00 AM to 11:30 AM (CEST)
Webinar Overview
With the EU Clinical Trial Regulation becoming effective on 31 January 2022, a new era of clinical trials with medicinal products has begun in the EU/EEA. The EU legislator provided for a 3-year transition period in which the former system under the EU Clinical Trials Directive and the new system under the EU Clinical Trial Regulation are available in parallel. Sponsors need to know how to best use this period for ongoing clinical trials, but maybe also for trials that are soon to be submitted. Strategic decisions will be necessary and the switch from one legal framework to the other must be well understood.
In this Webinar, the transitional provisions will be explained and different scenarios will be discussed around this topic. What is a harmonised trial protocol versus a consolidated protocol when making the switch from the old to the new system? And what happens to IMP on-site when transition from one system to the other is taking place? Many questions around the transition will be addressed in this Webinar. Finally, the CTR is offering new concepts in comparison to the EU Clinical Trials Directive (co-sponsorship, low-intervention clinical trials) – those topics will also be discussed in this Webinar.
This Webinar is the first of a series of Webinars EUCROF is offering to facilitate the understanding and future operational work with the CTR and the Clinical Trial Information System (CTIS). Don’t miss this opportunity!
Presenters
Dr Dagmar Chase
GCP Consultant and Trainer, Clinrex Munich (Germany).
Dagmar Chase graduated in Computer Science with a secondary focus on Theoretical Medicine from the Technical University in Munich and has 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. In 2019, the BPI e.V. appointed Dagmar Chase “BPI Senior Expert” in recognition of her knowledge and expertise in clinical research and GCP.
Attendance Fee
€ 90,- for non-EUCROF members
€ 60,- for EUCROF members
Deadline for registration
29 March 2022
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!
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