Report on WG Clinical Investigation and Evaluation
(CIE)
Wolfgang EckerFed. Min. of Health, Austria
Chairman CIECracow, 28-10-2011
CIEWork Plan - Achievements
Help develop regulatory system:Contributions to WG Recast wish list; options paper
Develop guidance:MEDDEV SAE-Reporting + summary tab form
MEDDEV PMCF-studies in final stage (GHTF)Individual SAE-reporting form in prep (GHTF)
EUDAMED CI module in operation:Yes and constantly improvingUnique identifier Electronic CI notification form for easier upload in prep
CIEWork Plan - Targets
Mirror group of SG 5:Last GHTF Guidance to transpose > PMCF-studiesContributions to SG1/SG5 TF on Clinical Evaluation of
IVDsContributions to SG2/SG5 TF on SAE-Reporting (esp
individual SAE-reporting form)
Exchange of opinions/experiences/best practice:Regularly done at CA-only sessions
CIE homepage:Yes, but it‘s not so easy to find us!
CIEWork Plan - Achievements
CIEWork Plan - Targets
Support Recast:Ready to help with specific drafting tasks
Ressource sharing/VHP/CAP:pilots to be planned for recast VHP/CAP?
Administrative CooperationForum for discussing critical issues in multinational trialsDevelop best practice guidance
Surveillance program:Implementation of 2007/47/EC in practice? MF/NB?
Program development together with COEN and NBOG
CIENext Steps
CIEWork Plan - Targets
Cooperation with Clinical societies, Registers, Pharma, HTA, Patients organizations, other stakeholders:
First steps (Orthopedics, Registers, Pharma [COM, HMA/CAMD], HTA) done
Define modalities and areas of cooperationIntensify contacts and cooperationIncrease transparency and active PR
Training, e-learning:First trial 2012?
CIENext Steps
Thank You!