The ICH GCP R3 Roadmap: Changes and Challenges of ICH E6 - Are you ready?

The ICH GCP R3 Roadmap: Changes and Challenges of ICH E6 (R3) –
Are you ready?

Date & Time: 17 June 2025 from 04:00 PM to 05:30 PM (CEST)

•The meeting will start at 04.00PM o’clock.
•Audio is available either through your computer or through phone connection (dial-in).
•Your line will be kept on mute.
•At the end, there will be time for questions and you can submit your questions
through the ‘question’ box.
•After the webinar, connect to the EUCROF eLearnIN platform (https://eucrof.eu)
to retrieve materials, customer satisfaction survey and certificate of attendance.
•At the end of the webinar, a Forum Discussion will be opened on the eLearnIN platform (https://eucrof.eu) to ask further questions to the speaker or start an open discussion on the topic of the 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.

Registration deadline: 16 June 2025 at 6 p.m.

________________________________________

By registering to the webinar, you give your authorisation to the webinar organisers 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 organisers directly at info@eucrof.eu.