These days there is lots of interest in the benefits, and challenges, of going electronic when it comes to submissions to Health Canada, as indicated by the turnout of more than 40 regulatory affairs professionals to an educational day-long workshop in Mississauga, Ontario today.
Representatives from Health Canada were on hand to answer questions and lend their support to the events’ sponsors – Regulatory Affairs Professionals Society (RAPS), LORENZ Life Sciences and Regxia. Their discussions confirmed that federal health agency reviewers already prefer electronic over paper submissions.
Craig Anderson, manager, regulatory affairs operation at AstraZeneca Canada, did a great overview of their experiences – highlighting the major benefits of eCTD, including the ability to do more with no change in headcount, and to reallocate budget previously spent on paper submissions to go instead into additional training programs for staff.
LORENZ Life Sciences, which is one of Adlib’s partners, did a demonstration of their new submission tool, the eValidator. It is used by Health Canada to validate eCTDs. Attendees were encouraged to actively interact with the submission software.
My own presentation – about how your submission success depends upon compliance with the eCTD guidelines and with the format of PDF files contained in it – was well received, with lots of questions about the use of PDF conversion, recognition and publishing solutions in the life sciences industry.
If you have any questions about how you can leverage the power of PDFs for the eCTD process, please drop me an email at firstname.lastname@example.org