Since the change in the EU submissions via CTIS system, I have a question how do you plan to file the Regulatory section in the eTMF? Do you plan to download the documents from the CTIS and file all in the REG section? We are currently discussing this subject in my company and I would like to hear how other companies plan this change into eTMF filing process. Thank you.
Hi Sylwia, this is an ongoing discussion in my organization, too.
Some tough nuts to crack – like the question if the redacted documents need to be in the TMF, or not.
But also questions if available non-eTMF solutions that can do a better job on submission dossier management should be considered as the repository for these documents (with a reference to that system in the eTMF).
Looking forward to hear thoughts and ideas from others.