© Safeguarding public health BIOABSORBABLE STENTS: REGULATORY ISSUES DR SUSANNE LUDGATE Clinical Director Medicines and Healthcare products Regulatory.

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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

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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

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CLINICAL INVESTIGATIONS

end points to demonstrate safety, performance, claims NOT randomised controlled numbers timescales investigating centres

Slide 6 2006MHRA

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OTHER FACTORS

training adverse event reporting CE marking when? humanitarian use

Slide 7 2006MHRA

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HUMANITARIAN USE

one –off named patient basis forms to complete (of course!) 24 hour turn around

Slide 8 2006MHRA

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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!”