Module 5 Presentations

05/07/2024

Simplifying the IMPD

• The IMPD is a dossier, not a stand-alone document. • Where relevant, cross-referencing – within current or to previous CTAs – within the IMPD • Where possible, reference CEP, Ph. Eur., JP or USP methods/specifications and remove related text

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Cross-Referencing Pin Board

Investigator’s Brochure

Non-Clinical

SmPC or ICH Region Equivalent

Regional Annexes

CEP

Drug Product

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