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Published bySilas Summers Modified over 8 years ago
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ABHI Presentation to RCS October 2011
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MD Regulatory Reform AGENDA EU Council Conclusions June 2011 What Needs Improving Industry Recommendation for New Framework
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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
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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
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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
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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
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