11 Oct. 2017 - EU Clinical Trials Regulation 536/2014: New Transparency Rules

Webinar Topic

EU Clinical Trials Regulation 536/2014: New Transparency Rules


Webinar Date & Time

11 October 2017 from 10:00 to 11:30 (CET)


Webinar Overview

Article 81 of the EU Clinical Trials Regulation 536/2014 refers to the EU Database and indicates what kind of information will be publicl'y accessible or will not be in the public domain, respectively.

In the “Appendix on Disclosure Rules to the “Functional Specifications for the EU Portal and EU Database to be audited – EMA/42176/2014”, very detailed rules are outlined as to what should be made public and when – classified in three trial categories:

Category 1: Phase I, Bioequivalence, Bioavailability, and Biosimilar Trials
Category 2: Phase II and Phase III Trials
Category 3: Phase IV and low-intervention Trials.
In the future, the phase of a trial will have a significant impact on the transparency rules to obey. It is also interesting to see what data will be made public. Trial protocol information and trial results are within all our expectations. However, we need to get used to the fact that – for example - serious breaches of the trial protocol or the Regulation will also be made public, as will inspection reports.

This Webinar will provide an overview of the new transparency rules. It will also cover the new draft “Guideline for the Notification of Serious Breaches of the Regulation (EU) No 536/2014 or the clinical trial protocol”.

After this Webinar, participants will have better awareness of future transparency rules and will be in a good position to analyze which procedures are missing in their companies, thus putting them in a better position to get “Regulation ready”.



Dr. Dagmar Chase

Managing Director

Clinrex GmbH

Munich, Germany

Chair of the EUCROF Clinical Trials Legislation Working Group


Attendance Fee

€ 90,- for EUCROF non-members

€ 60,- for EUCROF members only.


Deadline for registration

10 October 2017


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