abhi presentation to rcs n.
Download
Skip this Video
Loading SlideShow in 5 Seconds..
ABHI Presentation to RCS PowerPoint Presentation
Download Presentation
ABHI Presentation to RCS

Loading in 2 Seconds...

play fullscreen
1 / 6

ABHI Presentation to RCS - PowerPoint PPT Presentation


  • 74 Views
  • Uploaded on

ABHI Presentation to RCS. October 2011. MD Regulatory Reform. AGENDA EU Council Conclusions June 2011 What Needs Improving Industry Recommendation for New Framework. MD Regulatory Reform. EU Council Conclusions Innovation and the role of SME’s

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about 'ABHI Presentation to RCS' - marva


An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
md regulatory reform
MD Regulatory Reform

AGENDA

  • EU Council Conclusions June 2011
  • What Needs Improving
  • Industry Recommendation for New Framework
md regulatory reform1
MD Regulatory Reform

EU Council Conclusions

  • Innovation and the role of SME’s
  • Innovation that is safe, effective and timely
  • Further Development of Post-Marketing Surveillance and Vigilance
  • Transparency
  • Tighter Controls over Notified Bodies
md regulatory reform2
MD Regulatory Reform

Industry Recommendations

  • Current system has brought safe and innovative products to patients
  • Regulation needs to differentiate between devices and pharmaceuticals
  • Design Controls for Engineering Technologies
  • Previous successes; Orthopaedics, Stents, Cardiac Catheters
md regulatory reform3
MD Regulatory Reform

Improvements (1)

  • Notified Bodies
    • Designation and Control
    • Enhanced Accreditation Procedures
    • Training and Monitoring
  • PMS and Vigilance
    • Criteria for reporting, timelines and coordination
    • Central Reporting
    • Coordination between Authorities
md regulatory reform4
MD Regulatory Reform

Improvements (2)

  • Novel Technologies
    • New structures must not stifle innovation
    • Design Management
    • Scientific Support with clear direction
  • Transparency
    • Patient and citizen en-powerment
    • Use of Information Technology
    • Data basing