MHRA powerpoint template

Comments

Transcription

MHRA powerpoint template
Safeguarding public health
11th GHTF CONFERENCE
WASHINGTON DC
OCTOBER 2007
SG5: CLINICAL EVALUATION
STATUS REPORT
SUSANNE LUDGATE
Name MHRA
Date
2007
©
ROLE
to work towards convergence of clinical
evidence requirements to yield common
data for the purpose of acceptance by
global regulators
 harmonised definitions
 harmonised guidance
 MOU ISO TC 194
Safeguarding Public Health
MHRA
Slide 2
2007
©
MEMBERSHIP
 Commission, COCIR, EDMA, EUCOMED
 FDA, AdvaMed, NEMA
 Health Canada, MEDEC
 TGA, MIAA
 MHLW, JFMDA
Safeguarding Public Health
MHRA
Slide 3
2007
©
DOCUMENT FINALISED
clinical evidence: key definitions and concepts (N1R8)
 clinical investigation
 clinical data
 clinical evaluation
 clinical evidence
 process data generation, clinical evaluation
Safeguarding Public Health
MHRA
Slide 4
2007
©
DOCUMENT FINALISED
clinical evaluation (N2/R8)
 when, why, process
 general principles (scope, how performed, who performs)
 sources of data (experience, literature, investigation)
 appraisal
 analysis
 clinical evaluation report
Safeguarding Public Health
MHRA
Slide 5
2007
©
IMPLEMENTATION PLANS
 Japan: intending to implement
 EU: already implemented
 Australia: progress in implementation
 Canada: intentions incorporated in Regulations
 USA: law and definitions compatible
Safeguarding Public Health
MHRA
Slide 6
2007
©
DOCUMENT IN PROGRESS
IVD Subgroup (SG1)
Chair: Nancy Shadeed
“…..responsible for working on a harmonised
format for pre-market submissions…..”
Safeguarding Public Health
MHRA
Slide 7
2007
©
DOCUMENT IN PROGRESS
clinical investigation
 when undertaken/ general principles
 general principles need
 general principles design
 specific details design
 ethical considerations
Safeguarding Public Health
MHRA
Slide 8
2007
©
DOCUMENT IN PROGRESS
post-market clinical follow-up studies
 what is it
 when needed
 type of study
 plan, objectives
Safeguarding Public Health
MHRA
Slide 9
2007
©
OBSTACLES
 impact local law and regulations
 layers of review
 time to feedback
 lack mechanism to facilitate similar documents
Safeguarding Public Health
MHRA
Slide 10
2007
©
THE FUTURE…..
following completion of stated
documents…..
No further plans!!
Safeguarding Public Health
MHRA
Slide 11
2007
©

Similar documents