Dear Colleague,
Our second webinar is scheduled for March 5 at 17:00 CET and will discuss how patients can contribute to the ethical review of trials and products. As a public-private partnership, EUPATI is ideally placed to generate a broader dialogue on the importance of increased patient involvement in this area.
The upcoming Clinical Trial Regulation gives the following definition for an Ethics Committee:
(11) ‘Ethics committee’ means an independent body established in a Member State in accordance with the law of that Member State and empowered to give opinions for the purposes of this Regulation, taking into account the views of laypersons, in particular patients or patients' organisations;”
Article 9 requires that at least one lay person participates in the assessment of the application dossier.
Thus, not only the current but also the future clinical trial legislation will leave the decision to the EU Member States in which ways to include patients into ethical review of clinical trials. Stronger patient involvement in ethical review, however, is more and more considered to be very relevant to ensure that clinical trials really fulfill the patients’ needs and are better manageable. What are current best practices and considerations for future organization of ethical review in different EU Member States? How should the future look like?
Our upcoming EUPATI Webinar “How to enable meaningful patient contribution to ethical review?” will provide an opportunity to hear current experiences and expectations and to discuss your questions and suggestions.
If you wish to attend this webinar please register using our online form by February 26. From there you will receive pre-reading, the agenda and instructions on how to join. Please note the webinar will be conducted in English and will last for 90 minutes.
We look forward to hearing from you.
Best regards,
On behalf of EUPATI WP2 - Network Implementation
Ingrid Heyne
EUPATI Network Manager
European Forum for Good Clinical Practice Project Coordinator
E-mail: eupati@efgcp.eu
EUPATI Website: http://www.patientsacademy.eu
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