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Strategies for Global Labeling Management in Changing Reg Environment

Speaker: Gerrit Jan Nijveldt


If you are part of Regulatory – Labeling team in your company, you should not miss this Webinar. As you are constantly working to coordinate a more robust end-to-end labeling process, and trying to get yourself up to speed on the newest emerging regulations / guidances from FDA and EMA, MakroCare brings you this opportunity to learn about A-Z of Labeling to Global labeling process and practical challenges faced in day-to-day operations from our duo experts Gerrit-Jan Nijveldt, Senior Director, Regulatory Labeling, Sanofi and Carlos Langezaal, PhD, Director, Global Regulatory Affairs, Eisai, Inc. Some of the points being covered are listed below.

Gerrit’s Topic: “End-to-End Labeling: From Core Labeling Creation to Implementation

  • What is Core Labeling (short version)
  • How to update a CCDS
  • Implementation of core labeling
  • Tracking of implementation why how and what
  • Agency inspection of labeling implementation

Carlos’s Topic: Eisai’s Global Labeling Practices

  • Who is Eisai Global Labeling and who are the stakeholders
  • Eisai Global Labeling Function
  • Overview of Global Labeling process
  • Practical challenges