Regulatory Affairs with Veeva RIMS

Description

Urban Medical Academy’s regulatory affairs curriculum utilizes the Veeva vault RIMS cloud platform, unifying global submission and registration management. Students become fluent in the Natural language Processing (NLP) of compliance, documentation, and coordinated health authority interactions, mastering the end-to-end process of regulatory information management with tools adopted by leading life sciences organizations. Veeva Vault (RIMS) : The Veeva RIM family of applications is a comprehensive, cloud-based platform used to manage product and registration information, submission documents, and published dossiers. Veeva RIM provides a seamless and integrated approach to regulatory information management. RIM applications can be used alone or together within a single Vault.

• Veeva Registrationsis an end-to-end application for planning, tracking, and reporting of product and registration information, management of Health Authority interactions, and generation of IDMP messages.
• Veeva Submissionshelps users to manage the authoring, review, approval, and assembly of regulatory submissions content, such as clinical study reports, manufacturing information, nonclinical reports, summaries, and labeling. Veeva Submissions also includes binder templates that allow assembly of content into defined submissions structures, such as the eCTD.
• Veeva Submissions Archiveis designed to import, archive, and view published submissions that were previously submitted to Health Authorities. Regulatory Affairs users can easily import submissions into Vault, where those submissions are accessible by any user, anywhere across the globe. An integrated eCTD Viewer allows for quick review of content in each application and its submissions, as well as providing information on what other applications’ or submissions’ content was used.
• Veeva Submissions Publishingprovides an end-to-end publishing process to manage content planning, publishing, and finalizing submissions content in preparation for submitting to Health Authorities.