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Postmarketing Safety Management

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Module 4 Scheduled Launch Date: August 2014

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 

Introductory Offer: Buy all six modules and Save $600!
Offer expires August 31, 2014

Contact Information 

Linda Belmont, DIA
Phone +

Technical Requirements 

Click here for minimum system requirements.

Registration Fees 

Other Fees

Group Discounts

Introductory Offer: Buy all six modules and Save $600!
Offer expires August 31, 2014

The entire DIA Drug Safety eLearning Program can be purchased at a 25% discount ($1800) by August 31, 2014, which is a $600 discount off the total program price if each module were purchased individually.

When purchasing 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 25% discount on each item by August 31, 2014

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