Module 12 2019

To download any format that is needed by the member states

Minimum viable product (definition needed), e.g app vs web based Automatic conversion of tabulated information presented in Word or PDF

Flow of ePI exchange with NCAs

Level of granularity (MVP aspect)

Recognition of specific (QRD?) formatting and transcribing the information to the ePI schema Provide recommendation of exchange system, e.g. eCTD or CESP or SPOR or …

Automatic separation into QRD relevant sections taking into account the granularity needed for the ePI schema

Conversion of Word or PDF to ePI schema

Support for version control and version history

Support of automated translation

Makes use of SPOR information and available translations

The Organisation for Professionals in Regulatory Affairs