Regulatory Submissions, Information, and Document Management Forum

Proper planning and communication between medical writing and publishing can facilitate a clean handoff and minimize threats to the submission timeline. The handoff from medical writing to the publishing team is critical and often occurs at the “11th hour” of the overall submission timelines. Often, medical writing deliverables are on the critical path and compete with publishing directives for the medical writers’ attention. This session will detail common risks, risk mitigation, and establishing integrated workflows across functions. Presenters provide perspectives of a project manager, medical writer, and finally the publisher to cover the end-to-end process of submission documents.