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Bethesda North Marriott Hotel and Conference Center

Feb 08, 2016 12:00 PM - Feb 10, 2016 5:15 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

Discuss the end-to-end process for document management, publishing, and technical regulatory requirements in regulatory information management.

Session 5 Track 1 - Current Trends and Approaches to Managing Labeling Globally

Session Chair(s)

Sarah  Powell, RAC

Sarah Powell, RAC


Powell Regulatory Services, United States

This session will examine current trends within the Labeling organizations and how organizations are better positioning themselves to control and ensure proper and timely implementation of changes throughout global labeling.

Learning Objective : 1. Describe the history of global labeling alignment over the past several years and the industry trends for the future 2. Apply the best practices, identify the value of a program in your company, and assess your strategy 3. Plan your company’s next steps to address and act upon differences between the Company Core Data Sheet and the local country labels


Mauricha F. Marcussen, MBA

Global Labeling Alignment Trends and Best Practices

Mauricha F. Marcussen, MBA

Auditgraph, United States


Abhishek  Harde, MBA, MPharm, RAC

Global Labeling Management: Global Labeling – Collaborating With the Affiliates on Local Labeling

Abhishek Harde, MBA, MPharm, RAC

United States

Gerrit  Nijveldt, MSc

CCDS Process/Tracking

Gerrit Nijveldt, MSc

Opus Regulatory Inc., United States

Global Labeling Consultant

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