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Postmarketing Safety Management

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Overview 

This module is part of the DIA Drug Safety eLearning Program. The Postmarketing Safety Management module provides a framework and details around drug safety monitoring requirements for drugs after they are approved for marketing.

This module provides information about spontaneous reporting, aggregate reporting, risk assessment, benefit-risk management, risk management plans, and risk evaluation and mitigation strategies (REMS).

Featured Topics 

  • Spontaneous Case Reporting
  • Aggregate Reporting
  • Benefit-Risk Assessment
  • Risk Management Plans
  • Risk Evaluation and Mitigation Strategies (REMS)
  • Postmarketing Case Studies

Who Should Attend 

Professionals working in the area of:

  • Drug safety & pharmacovigilance
  • Clinical research and development
  • Marketing approval
  • Postmarketing activities
  • Regulatory and medical affairs
  • Quality assurance/compliance
  • Anyone who would like to enhance their knowledge and understanding of drug safety

Learning Objectives 

Upon completion of this course, participants should be able to:

  • Define spontaneous reporting and describe the spontaneous reporting system
  • Describe requirements for aggregate reporting of spontaneous reports
  • Describe the presentation of risks required in US labeling
  • Describe the efforts that have been made internationally to standardize benefit-risk assessment in the postmarketing phase
  • Describe risk management plan requirements in the EU
  • Describe risk evaluation and mitigation strategies (REMS) that are required in the US during postmarketing

Special Offers 

Buy all six modules and Save 20%!

Contact Information 

Linda Belmont, DIA
Phone +1.215.293.5818
Linda.Belmont@diahome.org

Technical Requirements 

Click here for minimum system requirements.

Registration Fees 

Other Fees

Individual
$400.00
Group Discounts

Modules from the DIA Drug Safety eLearning Program:

  • Purchase 2-5 modules and receive a 10% discount on each item
  • Purchase 6 modules and receive a 20% discount on each item

Register Online

Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.

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