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Monday, June 21 • 9:30am - 12:30pm
011A: #011A: Core Labeling

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Component Type: Tutorial
CE: ACPE 2.75 Knowledge UAN: 0286-0000-21-500-L04-P; CME 2.75; IACET 2.75; RN 2.75

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This half day short course will present the basic labeling requirements for global labeling documents. It will cover the concept of the Company Core Data Sheet (CCDS), the impact inside and outside of the company, how local labeling changes and regulatory requirements may have an impact on Company Core Data Sheet (CCDS). In addition, it will discuss the consequence for a company of having a CCDS and how that will impact local labeling and labeling departments. Need approval in order to attend? Download and fill out our Justification Letter to demonstrate to your supervisor why this is a must-attend event.
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Learning Objectives

Discuss the concept and use of Company Core Data Sheet (CCDS); Analyze with the detailed content of CCDS; Discuss knowledge of core labeling implementation and deviations; Identify options to bridge different local/regional requirements in the CCDS; Examine the potential impact of CCDS on the company, e.g. tracking, deviation management.

avatar for Gerrit Nijveldt

Gerrit Nijveldt

Consultant Labeling, Opus Regulatory, United States
Gerrit Nijveldt is currently Labeling consultant with Opus Regulatory. Gerrit has more than 20 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... Read More →

Monday June 21, 2021 9:30am - 12:30pm EDT
Virtual Event Virtual Event Horsham, PA 19044
  19: Short Courses, Tutorial |   01: ClinSafety-PV, Tutorial
  • Credit Type ACPE, CME, IACET, RN
  • Tags Tutorial