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Bethesda North Marriott Hotel and Conference Center

Apr 24, 2018 7:00 AM - Apr 25, 2018 3:00 PM

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

Global Labeling Conference

Session 8: Labeling Process, Document Management Systems, and Databases

Session Chair(s)

Gerrit  Nijveldt, MS, MSc

Gerrit Nijveldt, MS, MSc

Global Labeling Consultant

Opus Regulatory Inc., 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

End-to-End Labeling – A Vision for the Future

Jun Dong, PhD

ITS R&D, Sanofi, United States

Director, Business Partner for Global Regulatory Affairs and Development

Shimon  Yoshida, PhD

Transforming the Labeling Process: How an R&D Approach to Innovation Can Fuel the Future State

Shimon Yoshida, PhD

Pfizer Inc, United Kingdom

Executive Director, International Labeling Group, Global Regulatory Affairs

Julie P.  Retzinger, MBA, RN

Structured Authoring as a Tool for Globalization

Julie P. Retzinger, MBA, RN

Astellas Pharma Inc., United States

Senior Director - Global Labeling and CCDS

Camiel  Hoogendoorn, MSc

Structured Authoring as a Tool for Globalization

Camiel Hoogendoorn, MSc

Iperion / Astellas Pharma, Netherlands

Consultant IDMP

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