29 May 2015
Brussels, Belgium
A new Clinical Trials Regulation has been adopted by European legislation makers in 2014. This revised framework will bring significant advances regarding available public information about clinical research and its results compared to todays’ situation. Patients will for the first time be informed about clinical trial results in a layperson summary to better understand the value of their contribution.
We are now at a critical stage in the process where new rules have to be developed to implement legal requirements into daily research practice. Pragmatic guidance need to balance increased public information needs with seamless integration of new steps into global clinical research operations while safeguarding the privacy of participating patients, preserving the scientific rigor and trust in the regulatory systems and maintaining the incentives for investments into European biomedical research.
This workshop aims to facilitate a mutual dialogue among stakeholders to understand the wishes and expectations of patients and share experience and best practices of sponsors. An increased understanding of various options is essential to achieving a successful implementation of the new rules in a globalised research environment. More concretely, basic principles and specific tools that are consistent with health literacy principles will be discussed to help developing a framework that fully addresses stakeholder needs while increasing transparency and value for public health.
Registrations will be open soon!
For information, please contact the EFGCP Secretariat
(Tel: +32.2.732 87 83 - Email: conferences@efgcp.eu - Website: www.efgcp.eu)
More information here: www.luxclin.lu/Events/Details/?c=EVT5516UVY
for articles/videos/studies
Healthcare professionals who wish to be part of a unique network, providing access to up-to-date, accurate and validated information about clinical research.
Investigators and study staff who wish to be part of a unique network, in order to stay abreast of clinical trials taking place in Luxembourg and who are willing to further develop their competencies.
