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Omni Shoreham Hotel

Sep 11, 2016 10:00 AM - Sep 11, 2016 1:00 PM

2500 Calvert Street NW, , Washington, DC 20008 , USA

Course 1: From Investigator's Brochure to Worldwide Labeling


Short Courses are not included in the conference registration and require a separate registration fee.

Short Course Registration: 9:00AM-1:00PM

This short course will provide you with an essential understanding of the decision making principles for selecting adverse reactions for the purposes of Core Safety information and local submission labeling, and of the differing rules for generating adverse reaction frequency information. This knowledge will be helpful to labeling, regulatory affairs, pharmacovigilance, and clinical professionals, as well as biostatisticians, in avoiding frequent mistakes resulting from inappropriate application of definitions from the realm of clinical trial safety reporting.

Return to DIA Global Labeling 2016

Featured topics

  • The varying uses of the terms adverse event, suspected adverse reaction, adverse reaction, Development Core Safety information, Company Core Safety information, and reference safety information
  • The transition from clinical trial adverse event listings to a set of adverse reactions and their frequencies for labeling
  • Theory and practical application, including a practice exercise

Learning objectives

At the conclusion of this short course, participants should be able to:

  • Describe the conceptual differences between Development Core Safety Information and Reference Safety Information
  • Discuss the differences in the criteria for selecting adverse reactions for labeling, and suspected adverse reactions for regulatory reporting from clinical trials
  • Outline the various approaches to generating adverse reaction frequency information for labeling
  • Selecting a list of adverse reactions for labeling, based on adverse event data from clinical trials

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