Module 5 Presentations

05/07/2024

Quality Data - Regional Module • Where CE marked device used (e.g. novel delivery method) then the CE-mark certificate or Declaration of Conformity may be attached • Additional information on investigational MD? Consult with the national RA for document requirements and application process • Regional module also commonly used for biosimilar demonstration of similarity

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IND to IMPD Tips

Most content can be reused but a direct 1-2-1 replacement is not viable. Care to be taken, e.g.:

S.2.1, P.3.1 Manufacturer(s) – Check includes sites relevant for EU, particularly release and, for biologicals, GMP cert. or QP dec. availability

P.4 Control of Excipients & P.5 Control of the IMP – Check for applicable EU monographs

P.4.3, P.5.3 Validation of Analytical Procedures – no need for validation reports, you must summarise results

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