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Session 8: Labeling Process, Document Management Systems, and Databases
Session Chair(s)
Gerrit Nijveldt, MS, MSC
Global Labeling Consultant , Opus Regulatory, United States
Up-to-date data management systems are increasingly important to comply with SPL requirements in the US and IDMP in the EU, especially for the labeling function, which must look at the complete set of data needed for global and compliance. Labeling groups also frequently employ content authoring systems to consistently apply the data and updates in regulatory documents. This session will discuss the advantages and limitations of content authoring, its relation to data management, and the downstream use of systems that can integrate content and data as possible tracking tools for countries/affiliates.
Learning Objective : At the conclusion of this session, participants should be able to:- Describe the concepts of content authoring for labeling
- Identify advantages and limitations of content authoring for labeling
- Discuss data needs and the importance of data management for labeling related data
Speaker(s)
Jun Dong, PHD
Director, Business Partner for Global Regulatory Affairs and Development, ITS R&D, Sanofi, United States
End-to-End Labeling – A Vision for the Future
Shimon Yoshida, PHD
Executive Director, International Labeling Group, Global Regulatory Affairs, Pfizer Inc, United Kingdom
Transforming the Labeling Process: How an R&D Approach to Innovation Can Fuel the Future State
Julie P. Retzinger, MBA, RN
Senior Director - Global Labeling and CCDS, Astellas Pharma Inc., United States
Structured Authoring as a Tool for Globalization
Camiel Hoogendoorn, MSC
Consultant IDMP, Iperion / Astellas Pharma, Netherlands
Structured Authoring as a Tool for Globalization
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