1. © Safeguarding public health BIOABSORBABLE STENTS: REGULATORY ISSUES DR SUSANNE LUDGATE Clinical Director Medicines and Healthcare products Regulatory Agency, UK  NameMHRA  Date2006

2.  NO CONFLICT OF INTEREST TO DECLARE

3. Slide 3 2006 MHRA Safeguarding Public Health © EU REGULATORY SYSTEM compliance ERs safety, performance provide ifu Notified Body quality systems design dossier clinical data ifu pmcf plan pms plan accredit audit Competent Authority European market investigation action, including recall, safeguard clinical investigation humanitarian use post market surveillance vigilance

4. Slide 4 2006 MHRA Safeguarding Public Health © 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

5. Slide 5 2006 MHRA Safeguarding Public Health © CLINICAL INVESTIGATIONS  end points to demonstrate safety, performance, claims  NOT randomised controlled  numbers  timescales  investigating centres

6. Slide 6 2006 MHRA Safeguarding Public Health © OTHER FACTORS  training  adverse event reporting  CE marking when?  humanitarian use

7. Slide 7 2006 MHRA Safeguarding Public Health © HUMANITARIAN USE  one –off  named patient basis  forms to complete (of course!)  24 hour turn around

8. Slide 8 2006 MHRA Safeguarding Public Health © POST-MARKET “ …an undertaking by the manufacturer to institute and keep up-dated a POST MARKET SURVEILLANCE SYSTEM…”  post market clinical plan  extension clinical trial  cohort study  sub-population studies  registers  adverse incident reporting including ifu

9. Slide 9 2006 MHRA Safeguarding Public Health © 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!”