Systems and methods for processing global regulatory submissions
Systems and methods for optimized processing of global regulatory submissions to health authorities. A content management system provides an end-to-end solution for submitting regulatory documents, from authoring through uploading to a health authority gateway. The content management system creates, manages and consigns submission content plans for a regulatory event requiring regulatory approval based on a global content plan. The content plans may be generated based on content plan templates which may take into account submission information and can be dispatched separately by sections, components, or groupings. The global and local submission plans are collated to generate a comparison. A comparison viewer user interface displays the side by side hierarchical comparison of global with submission content plan where each row is a content plan item with differences highlighted.
1 . A computer-implemented method for processing global regulatory submissions in a content management system, wherein the content management system comprises a content management server comprising a submission controller stored in memory and executable by a processor, and a plurality of repositories, the computer-implemented method comprising:
creating, by the submission controller, a first content plan for regulatory submission for a regulatory event, wherein the first content plan includes a first and second submission document required for regulatory approval;
asynchronously dispatching, by the submission controller, at least the first submission document to a first affiliate for completion for regulatory submission;
asynchronously dispatching, by the submission controller, at least the second submission document to a second affiliate for completion for regulatory submission;
creating, by the submission controller, a second content plan for regulatory submission, wherein the second content plan includes the dispatched at least first submission document required for regulatory approval;
creating, by the submission controller, a third content plan for regulatory submission, wherein the third content plan includes the dispatched at least second submission document required for regulatory approval;
collating, by the submission controller using a translation layer that maps content plan items between different content plan templates, the first content plan and the second content plan to generate a comparison between each corresponding content plan item in the first and second content plan;
generating, by the submission controller, a comparison viewer user interface displaying a hierarchical representation of the comparison between the first content plan and the second content plan, wherein new, updated and removed documents are visually differentiated using color coding or shading to designate the correlation between the first content plan and the second content plan;
receiving input from the comparison viewer user interface confirming approval of selected content plan items in the second content plan; and
storing, by the submission controller, each of the selected content plan items in the second content plan in a submission repository in the content management system
wherein the submission controller continuously monitors documents in the content storage system for any changes that might affect publishing, and wherein the changes are updated in real-time, eliminating the possibility of human error and ensuring faster time to submission.
2 . The computer-implemented method of claim 1 above, wherein the first content plan for regulatory submission is a global content plan.
3 . The computer-implemented method of claim 1 above, wherein the second content plan for regulatory submission is a submission content plan for a regional or local submission.
4 . The computer-implemented method of claim 1 above, wherein the third content plan for regulatory submission is a submission content plan for a regional or local submission.
5 . The computer-implemented method of claim 1 above, wherein the asynchronously dispatching of at least the first submission document to the first affiliate for completion for regulatory submission includes dispatching one component of the first submission document to the first affiliate for completion for regulatory submission.
6 . The computer-implemented method of claim 1 above, wherein the asynchronously dispatching of at least the second submission document to the second affiliate for completion for regulatory submission includes dispatching one component of the second submission document to the second affiliate for completion for regulatory submission.
7 . The computer-implemented method of claim 1 above, further comprising publishing the second content plan to an archive in the content management system; and validating the second content plan against a first validation criterion, wherein the first validation criterion is based on a regulatory requirement.
8 . The computer-implemented method of claim 7 above, further comprising publishing the third content plan to an archive in the content management system; and validating the third content plan against a first validation criterion, wherein the first validation criterion is based on a regulatory requirement.
9 . The computer-implemented method of claim 1 above, further comprising publishing the third content plan to an archive in the content management system; and validating the third content plan against a second validation criterion, wherein the second validation criterion is based on a regulatory requirement.
10 . The computer-implemented method of claim 1 , further comprising uploading the second content plan from the content management system to an electronic gateway over a network in response to a user input.
11 . The computer-implemented method of claim 10 above, further comprising uploading the third content plan from the content management system to an electronic gateway over a network in response to a user input.
12 . The computer-implemented method of claim 1 above, wherein the regulatory event comprises introduction of a new product.
13 . The computer-implemented method of claim 1 above, wherein the regulatory event comprises a change to an existing product.
14 . The computer-implemented method of claim 1 above, wherein the creation of the second content plan is based on a content plan template that takes into account submission information.
15 . The computer-implemented method of claim 14 above, wherein the submission information includes at least one selected from: country, region, submission type, involved product, and regional requirements.
16 . The computer-implemented method of claim 14 above, wherein the content plan template is an electronic common technical document (“eCTD”).
17 . The computer-implemented method of claim 14 above, wherein the content plan template consists of one selected from the following: an electronic common technical document, a country specific submission template, or a country specific investigational template.
18 . The computer-implemented method of claim 1 above, further comprising: collating the first content plan and the third content plan to generate a comparison between each corresponding content plan item in the first and third content plan.
19 . The computer-implemented method of claim 1 above, further comprising: collating the first content plan and the third content plan to asynchronously generate a comparison between each corresponding content plan item in the first and third content plan.