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EU Clinical Trials Regulation 536/2014: Protection of Subjects and Informed...

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>> Webinar Topic:

EU Clinical Trials Regulation 536/2014: Protection of Subjects and Informed Consent.

>> Webinar Date & Time:

10th May 2017 from 10:00 to 11:30 (CET)

>> Webinar Overview:

Chapter V of the EU Clinical Trials Regulation 536/2014 covers the important topic of protection of subjects and informed consent in a comprehensive manner. Regarding the informed consent procedure, the Regulation clearly formulates the framework for different (vulnerable) populations, however so called opening clauses provide the national legislators with important flexibility as to the provision of corresponding national rules which aim to mirror the local perception of ethics on these topics.

This Webinar will provide an overview of Chapter V, pointing out those elements for which one should be alert for local implementation in the different Member States. In addition, the required elements for an informed consent form (ICF) will be compared with those set out in ICH-GCP.

After this Webinar, participants will have better awareness of clinical trials designed for individual subject benefit versus those designed for group benefit and of their use in different types of (vulnerable) populations.


>> Presenter:

Dr. Dagmar Chase

Managing Director

Clinrex GmbH

Munich, Germany


>> Attendance Fee:

€ 90,- for EUCROF non-members

€ 60,- for EUCROF members only.

>> Deadline for registration:

9th May 2017



>> How to register?

1) Click on the green "REGISTER" button on Eventbrite

2) Check your order and click on the green "CHECKOUT" button

3) Fill in all necessaary informations and validate your order


>> Confirmation

You will receive 2 confirmations email :

A) One from Eventbrite with you invoice

B) One from "GoToWebinar", our new Webinar platform, with all necessary informaiton to connect the D-Day!

>> Questions?

Should you have any questions about registration, invoices or connexion, do not hesitate to contact us by email webinar@eucrof.eu.

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