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Name MHRA Date 2007

A comprehensive report by Susanne Ludgate detailing the effort towards convergence of clinical evidence requirements for global regulatory acceptance, including key definitions, concepts, and implementation plans in various regions. Addressing obstacles and future perspectives.

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Name MHRA Date 2007

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  1. 11th GHTF CONFERENCEWASHINGTON DCOCTOBER 2007SG5: CLINICAL EVALUATIONSTATUS REPORTSUSANNE LUDGATE Name MHRA Date 2007

  2. 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

  3. MEMBERSHIP • Commission, COCIR, EDMA, EUCOMED • FDA, AdvaMed, NEMA • Health Canada, MEDEC • TGA, MIAA • MHLW, JFMDA

  4. DOCUMENT FINALISED • clinical investigation • clinical data • clinical evaluation • clinical evidence • process data generation, clinical evaluation clinical evidence: key definitions and concepts (N1R8)

  5. DOCUMENT FINALISED • when, why, process • general principles (scope, how performed, who performs) • sources of data (experience, literature, investigation) • appraisal • analysis • clinical evaluation report clinical evaluation (N2/R8)

  6. IMPLEMENTATION PLANS • Japan: intending to implement • EU: already implemented • Australia: progress in implementation • Canada: intentions incorporated in Regulations • USA: law and definitions compatible

  7. DOCUMENT IN PROGRESS IVD Subgroup (SG1) Chair: Nancy Shadeed “…..responsible for working on a harmonised format for pre-market submissions…..”

  8. DOCUMENT IN PROGRESS • when undertaken/ general principles • general principles need • general principles design • specific details design • ethical considerations clinical investigation

  9. DOCUMENT IN PROGRESS • what is it • when needed • type of study • plan, objectives post-market clinical follow-up studies

  10. OBSTACLES • impact local law and regulations • layers of review • time to feedback • lack mechanism to facilitate similar documents

  11. THE FUTURE….. following completion of stated documents….. No further plans!!

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