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Safeguarding public health
BIOABSORBABLE STENTS:REGULATORY ISSUES
DR SUSANNE LUDGATE
Clinical Director
Medicines and Healthcare products Regulatory Agency, UK
Name MHRADate 2006
NO CONFLICT OF INTEREST TO DECLARE
Slide 3 2006MHRA
Safeguarding Public Health
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EU REGULATORY SYSTEM
compliance ERssafety, performance
provide ifu
Notified Body• quality systems• design dossier• clinical data• ifu• pmcf plan• pms plan
accreditaudit
CompetentAuthority
European market
investigation action, including recall, safeguard
• clinical investigation• humanitarian use
• post market surveillance • vigilance
Slide 4 2006MHRA
Safeguarding Public Health
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CLINICAL INVESTIGATION
clinical (previous experience, inclusion, exclusion, end points, duration) radiological (OCT, MSCT) / other investigations materials (tensile strength, radial force, balloon life, speed deflation) biological safety (animal studies) biocompatibility (thrombogenicity, complement, haemolysis) sterilisation validation shelf life, special storage conditions drug - qualitative, quantitative details
- method of manufacture- control tests- stability- local tolerance- pharmacokinetics- clinical data
Slide 5 2006MHRA
Safeguarding Public Health
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CLINICAL INVESTIGATIONS
end points to demonstrate safety, performance, claims NOT randomised controlled numbers timescales investigating centres
Slide 6 2006MHRA
Safeguarding Public Health
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OTHER FACTORS
training adverse event reporting CE marking when? humanitarian use
Slide 7 2006MHRA
Safeguarding Public Health
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HUMANITARIAN USE
one –off named patient basis forms to complete (of course!) 24 hour turn around
Slide 8 2006MHRA
Safeguarding Public Health
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POST-MARKET
“ …an undertaking by the manufacturerto institute and keep up-dated a POSTMARKET SURVEILLANCE SYSTEM…”
post market clinical plan extension clinical trial cohort study sub-population studies registers
adverse incident reporting including ifu
Slide 9 2006MHRA
Safeguarding Public Health
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CLINICIAN INPUT
is the protocol designed to deliver (short, long term) meeting/teleconference with MHRA, manufacturer ensure adequate training consider humanitarian use remember post CE marking protocols, collect data report all adverse events to MHRA consider carefully off-label use (data collection) discuss problems early with MHRA
“we’re from the government and are here to help!”