The European Medicines Agency is just months away from simultaneously easing the onerous process of product information review for regulatory submissions--for drug developers and regulators alike--and wreaking process havoc within life sciences companies. The regulator is slated to move from pilot to production of the PIM (for product information management) standard for product labeling in regulatory submissions in mid-2011.
PIM helps European regulators communicate with drug developers on marketing authorizations. "It's more than just the transmission of data," says Mike Webb, executive chairman at Virtify, in an interview. "It affects the broader process of generating product information for submission, circulating it for review and the accompanying version tracking and deadline management usually accomplished via spreadsheet." Drug developers anywhere in the world wanting to market their wares in Europe are affected.
That's why the Cambridge, MA, software maker has developed PIM Enterprise, an automated XML-generation and translation management tool, to be available next month. "Everyone is getting up to speed," Webb says. "Managing a PIM submission is not a trivial undertaking, especially for companies using manual processes and traditional document management systems," Webb says. One of PIM's goals is to cut down on the repetition of content across documents and across European countries via centralized XML submission.
PIM Enterprise, a standalone offering that is part of Virtify's Enterprise Content Compliance suite, provides automated compliance assistance with the labeling standard. The collaborative Internet-based tool generates PIM submissions using a structured content approach in which users can work at the PIM element and PIM fragment levels, so authors and reviewers can work in parallel on different sections of one or more PIM submissions. That should be a big time-saver over the existing process, which involves document exchanges between submitter and regulator and serial review/revision efforts.
- here's the Virtify release
- see more about PIM