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Virtual

13 jun 2023 1:00 p.m. - 13 jun 2023 4:00 p.m.

Global Labeling: The Basics of Core Datasheet

Instructors

Mo  Lamplugh

Mo Lamplugh

Coordinator, DIA, Japan

Please provide a brief biography which will be used for introductory purposes within the program offering and will be shared with other Program Participants. (maximum 500 characters) Please provide a brief biography which will be used for introductory purposes within the program offering and will be shared with other Program Participants. (maximum 500 characters) Please provide a brief biography which will be used for introductory purposes within the program offering and will be shared with other Program Participants. (maximum 500 characters) Please provide a brief biography which will be used for introductory purposes within the program offering and will be shared with other Program Participants. (maximum 500 characters) Please provide a b

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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