Clinical Trials Workshop II - Translating the New Transparency Requirements into Practice

New EU requirements are expected to come into force during 2014, impacting clinical trial processes including informed consent as well as the provision of public access to information and results of clinical trials. This workshop will review the new transparency requirements and voluntary commitments and, describe how these will impact current disclosure procedures. There will be a focus on sharing experiences on how the requirements are being implemented in practise.

The two day workshop will address the Transparency aspects of the new Clinical Trials Regulation expected to become applicable in 2016, the EMA clinical data transparency policy expected to be published in its final version for implementation later in 2014, and implementation of the clinical trials results submission to EudraCT for public disclosure via the EU Clinical Trials Register. The EU results requirements via EudraCT is to come in force by the finalisation of the next version update of EudraCT, expected mid 2014. The workshop will also address how these initiatives relate to the EFPIA-PhRMA 'Principles for Responsible Data Sharing' and how industry is implementing the Principles.

An adjacent 2-day workshop on the new Clinical Trials Regulation, will offer an opportunity for attendees to focus on conceptual and practical aspects of implementation of the new Regulation. Attendees can participate in either one workshop or in the entire 3-day program. The two workshops will overlap with a day addressing the Transparency aspects of the Clinical Trials Regulation.