Webinar Date & Time
17 June 2025 from 04:00 PM to 05:30 PM (CEST)
Webinar Overview
In the EU, the ICH Guideline E6 (R3) will be effective on 23 July 2025. The guideline underwent a major restructuring and modernisation. The risk-based and risk-proportionate approach has been introduced into every aspect of a clinical trial and modern techniques like the use of computerized systems (e.g., eCRF, eTMF, eConsent), as well as remote Source Data Verification are now included in the Guideline. Data Governance plays an important role, not only for sponsors but also for investigators.
Although the GCP wheel has not been re-invented, we all need to get familiarised with the new approaches and elements of the Guideline. The approximate 6 months between the adoption of the Guideline by the EMA and the coming into effect should be smartly used to get your teams trained, to revisit your SOPs and to bring them up-to-date. Solid knowledge of the changes and challenges of the new Guideline will ease the revision of your GCP Quality Management System (QMS).
Don’t miss this EUCROF Webinar – you, your QMS, your clinical trials and ultimately the trial participants will benefit from your good GCP knowledge.
Presenter
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 and training firm for clinical research with a focus on GCP.
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.
Attendance Fee
€ 90,- for non-EUCROF members
€ 60,- for EUCROF members
Deadline for registration
16 June 2025 at 6 p.m.
How to register?
1) Go on the REGISTRATION PAGE and click on the orange button “GET TICKETS”
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 “Eucrof” with all the necessary information to connect the D-Day!
Questions?
Should you have any questions about registration, invoices or connection, do not hesitate and contact us by email at webinar@eucrof.eu
By registering to the webinar, you give your authorisation to the webinar organizers to use your email address and personal information to communicate with you about this event and future initiatives. To stop receiving their communications, please contact the organizers directly at info@eucrof.eu.
