MHRA powerpoint template - TOPRA

More documents

Recommendations

Info

GENERAL PRINCIPLESDESIGN based on results clinical evaluation process follow a risk management procedure compliant with all relevant legal, regulatory requirements appropriately designed• factors influencing extent data requirements• objectives, endpoints• justification parameters including numbers• minimisation of bias• design configuration follow appropriate ethical principlesSafeguarding Public Health<strong>MHRA</strong>Slide 242010©
ISSUES pre-market testing inadequate to justify safety parameters not applicable/inadequate (time, numbers) stopped too early CE marked outwith data demonstrated by trial no pmcf plan/justification for absenceSafeguarding Public Health<strong>MHRA</strong>Slide 252010©
Page 1 and 2: Safeguarding public healthCLINICAL
Page 3 and 4: NHS NEGLIGANCE2009/10£827,367,000S
Page 5 and 6: NUMBERS/CLAIM VALUESafeguarding Pub
Page 7 and 8: EU REGULATORY SYSTEMarticle 20inves
Page 9 and 10: CLINICAL DATA“……..as a genera
Page 11 and 12: ESSENTIALREQUIREMENTS“…..demons
Page 13 and 14: GHTF DOCUMENTS clinical evidence: d
Page 15 and 16: SOURCES OF DATA literature searchin
Page 17 and 18: APPRAISAL suitability of data type
Page 19 and 20: STAGES EVALUATIONidentify clinical
Page 21 and 22: ? EQUIVALENCE atrial appendage plug
Page 23: CLINICAL INVESTIGATION when underta
Page 27 and 28: ENDPOINTS clinical investigation re
Page 29 and 30: PMCFpost-market clinical follow-up
Page 31 and 32: SUMMARY the requirements Directives

MHRA powerpoint template - TOPRA

Create successful ePaper yourself

Delete template?

Save as template?