10th May, 2017 - EU Clinical Trials Regulation 536/2014: Protection of Subjects and Informed Consent.

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.



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?

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

3) Fill in all necessaary informations and validate your order



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