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Virtual

Apr 01, 2022 1:00 PM - Apr 01, 2022 5:00 PM

(US Eastern Standard Time)

Beyond the Basics of the Core Data Sheet: A Practical Approach to Regional Considerations

Overview

This Short Course is intended to build on the Basic understanding of Company Core Datasheets. It will provide a practical experience to illustrate the regional (e.g. EU, US and Japan) considerations which can influence CCDS decision making. The course will consider key core safety sections of the labeling and the impact of Agency labeling requests. The course will be based around case studies.


*Short Courses require an additional registration fee. You do not need to be registered for the forum to attend*

This Short Course will be offering in a virtual format only


Learning objectives

At the conclusion of this short course, participants should be able to:
  • Identify core safety topics which differ between regions
  • Identify common regional core safety topics for inclusion into a CCDS
  • Identify potential impact of health authority requests on CCDS texts

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