Description: This session explores staged approach to implementation of systems from manual processes to automated work flows to robust software solutions for the management of Medical, Legal, Regulatory review of advertising and educational materials.
This session presents a case study of how a fast-growing global medical device manufacturer successfully transitioned from an ad hoc promotional review process to a scalable Medical-Legal-Regulatory (MLR) review system aligned with Global Regulations. The presentation will explore the staged approach to implementation of systems from manual processes to automated workflows to robust software solutions for the management of Medical, Legal, Regulatory review of advertising and educational materials. Including walk through of key decision points, stakeholder engagement, and compliance risk mitigation.
Attendees will gain insight into how system requirements evolved from start-up operations to enterprise-level compliance, with lessons learned from both implementation and optimization phases.
The presentation concludes with metrics on system adoption, global harmonization, and regulatory outcomes that demonstrate the impact of a well-designed MLR system.
Learning Objectives:
Understand the global landscape of regulations and local laws impacting Advertising and Educational Materials.
Identify common MLR process pitfalls during early-stage adoption and scale-up.
Apply lessons from a real-world implementation to build or enhance their organization’s MLR infrastructure.
