Table of contents The table of contents may include the following information:— Centr ...

Preclinical testing Summary of preclinical testing that has been performed on the i ...

Clinical investigation team Briefly describe the administrative structure of the clin ...

PROVIDED that the requirement of Transmissible Spongiform Encephalopathies (TSEs) or ...

(ii) Evidence of the ongoing revalidation of the process should also be provided. Typ ...

7.2 Bio-compatibility: (i) The dossier should contain a list of all materials in dire ...

8.0 Specimen type: (a) This section should describe the different specimen types that ...

14.0 Definition of Assay Cut-off: This section should provide a summary of analytical ...