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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
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