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2016 年 02 月 08 日 12:00 下午 - 2016 年 02 月 10 日 5:15 下午

Regulatory Submissions, Information, and Document Management Forum

Session Chair(s)

Sarah  Powell, RAC

Sarah Powell, RAC

President

Powell Regulatory Services, United States

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

Speaker(s)

Mauricha F. Marcussen, MBA

Global Labeling Alignment Trends and Best Practices

Mauricha F. Marcussen, MBA

Auditgraph, United States

Founder

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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