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FDA’s New Final Rule for Electronic Drug Registration and Listing: What’s Changing? What’s Not?

Presenters

John  Lorenc

John Lorenc

Senior Product Manager, Life Sciences, Reed Tech, United States

Jon  Nolan

Jon Nolan

Associate Product Manager, Reed Tech, United States

Gerrit  Nijveldt, MSc

Gerrit Nijveldt, MSc

Global Labeling Consultant , Opus Regulatory Inc., United States

Gerrit Nijveldt is currently Labeling consultant with Opus Regulatory. Gerrit has more than 25 years of experience in Global labeling. He has a broad experience in developing and maintaining Company Core Data Sheets, US Prescribing Information and EU Summary of Product Characterisation, including the labeling for multiple development products (early phase to approval) and labeling for devices. Gerrit was also an associate adjunct professor for Temple University School of Pharmacy teaching Global Labeling in the RA/QA Master’s Program till 2022. Gerrit earned his MSc in Medical Biology from University of Utrecht in the Netherlands

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