report on wg clinical investigation and evaluation (cie) wolfgang ecker fed. min. of health, austria...

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!