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A Cloud-Based Approach to Evaluating and Maintaining Global Regulatory Content Alignment

Track:
Processes and Technologies for Clinical Research

Day & Time:
June 18, 1:30PM - 3:00PM (Pacific Standard Time)

Session Number:
361

Room Number:
33AB

Level:
Basic

Type:
Session

Title:
A Cloud-Based Approach to Evaluating and Maintaining Global Regulatory Content Alignment

Chair(s):
Mauricha F. Marcussen, MBA
Chief Executive Officer
Auditgraph, United States

Description:
This session will also cover the choice to use a SaaS-based deployment model and the business rationale behind this decision. Through the sharing of a case study, the audience will learn how the formation of an integrated technology approach is key to the success of these projects. Finally, the technology solutions will be tied back to the critical business needs and the successful progression towards the company’s global compliance objectives.


Learning Objective(s):
Evaluate the impact of cloud-based content comparison technologies in their organization based on relevant business cases presented; Propose process refinements that leverage these technologies to automate and simplify alignment efforts.

Presentation(s) & Speaker(s):
Industry Trends for Successful Global Label Alignment
Tracy D. Rockney, JD
Vice President, Regulatory Affairs, Global Labeling, Advertising and Promotion
AbbVie Inc., United States

Global Label Harmonization and Compliance: A Case Study
Mauricha F. Marcussen, MBA
Chief Executive Officer
Auditgraph, United States

Cloud Technology, Analytics, and Reporting for Global Labeling Compliance
Michael Timothy Hoey
Chief Technology Officer
RxCloud LLP, United States