© safeguarding public health bioabsorbable stents: regulatory issues dr susanne ludgate clinical...
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![Page 1: © Safeguarding public health BIOABSORBABLE STENTS: REGULATORY ISSUES DR SUSANNE LUDGATE Clinical Director Medicines and Healthcare products Regulatory](https://reader036.vdocuments.mx/reader036/viewer/2022062421/56649d0f5503460f949e4e38/html5/thumbnails/1.jpg)
©
Safeguarding public health
BIOABSORBABLE STENTS:REGULATORY ISSUES
DR SUSANNE LUDGATE
Clinical Director
Medicines and Healthcare products Regulatory Agency, UK
Name MHRADate 2006
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NO CONFLICT OF INTEREST TO DECLARE
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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
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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
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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
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Slide 6 2006MHRA
Safeguarding Public Health
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OTHER FACTORS
training adverse event reporting CE marking when? humanitarian use
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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
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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
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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!”