Posted Thu, 07 Sep 2023 07:06:13 GMT by Cristina Pepato

Dear PLM Portal Users,  

We are pleased to announce that new guidance & training materials are now available to support electronic product information (ePI) pilot participants in accessing and navigating through the platform and successfully taking part in the pilot. 

In the PLM Portal, it is now possible to find: 

- The ePI registration guide which supports ePI pilot participants in completing the steps needed to gain access to the platform to manage ePI. 

- The ePI procedural guidance which describes ePI processes within regulatory procedure timeframes for applicants participating in the ePI pilot. 

- The ePI user guide for applicants which describes how to create, author, and submit electronic Product Information (ePI) for regulatory approval and publication.  

ePI videos to support users with the functionalities of the PLM portal for ePI. This section currently contains the video tour of the portal but will be updated with more content related to ePI creation and management. 

- The ePI Frequently Asked Questions (FAQ) document which answers common questions by ePI pilot participants. 

- The list of ePI known issues which details issues in the ePI section of the PLM Portal that the ePI team is aware of and workarounds where available. It is not necessary to open a Service Desk ticket for these issues. 

Important note: ePI roles are currently only available to participants in the ePI pilot. 

Please note that the guides will be updated regularly and any feedback from users is welcome.