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T 41: Enabling Global Regulatory Submission Project and Portfolio Management

Poster Presenter

Matthew Pazdernik

Director
Merck & Co., Inc
United Kingdom

Objectives

Enable global regulatory submission portfolio planning and project management through integrated processes and innovative technologies.

Method

Development of a Portfolio Submission Project Management (PSPM) tool based in Microsoft Project Server with integrated connections to an Appian portal interface. Co-Author: Zach Huggins

Results

PSPM Tool and supporting processes deliver the planning capability to support global regulatory submissions. This includes several key capabilities, including: ability to develop a Central Plan (with components authored at headquarters) linked to a Regional Plan (with modified, translated, or locally authored components for a particular country filing). Enables a single location for planners to update high-level milestones (provides visibility into the submission lifecycle) and component-level planning information (the documents and subtasks required to execute the submission). Provides a means for Country Regulatory Affairs staff to access documents authored at HQ, and also provides the capability for Country RA staff to be assigned and complete tasks (via interaction with the RIM Portal). As a result of implementing PSPM, we have the ability to view the entire portfolio of regulatory submission work, including the lifecycle status of each submission (Plan Baselined, Plan Complete, Publishing Complete, Agency Submission, Agency Decision), the planned and actual dates achieved (with reasons for delayed milestones), and drill down capability to review the specific documents provided for each country regulatory filing (and the corresponding headquarters-authored document for documents which are modified, translated, or redacted at the local level). The output of PSPM is a work order for the publishing team to assemble and release the submission to the health authority, which doubles as an archivable report with links to the specific documents used in the submission. Business impact is transparency and visiblity of each regulatory filing status across the portfolio, enabling robust portfolio management and ultimately prioritization and resource management decisions. In addition, the tool and process drive significant impact in increasing 'right-first-time' quality and reducing cycle time and rework for filings in major markets and around the world.

Conclusion

Implementing PSPM tool has already had several benefits - planners benefit from a common platform for entering milestone information and project managing submission components, countries benefit from greater visibility into upcoming work and the ability to provide input during the planning stages (rather than reworking documents sent to them by HQ), content authors benefit from having a dashboard of assigned work and a straightforward method by which to provide their completed documents, and regulatory affairs management benefits from the visibility and analytics of all regulatory submission activity. PSPM tool has integrated several disparate activities conducted by various roles within Regulatory Affairs Operations - it has made their jobs easier, the published submissions more consistent, and the process of planning and executing submissions around the world more transparent and more efficient.