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Risk Management for the Pharmaceutical Industry

The pharmaceutical industry and drug development process pose challenges that vary significantly from standard project management practices, especially in the area of risk management. Risk management is an integral part of project planning; it is not a separate process. It includes the processes concerned with conducting risk management planning identification, analysis, responses plus monitoring and control on a project. The objectives of project risk management are to maximize positive outcomes by increasing the probability and impact of positive events, and minimize the negative outcomes by decreasing the probability and impact of events adverse to a project.

Learning Objectives

  • List the five processes of project risk management
  • Apply at least one risk identification technique to create a risk statement
  • Complete the Probability-Impact Matrix for a given risk to perform risk analysis
  • Recognize the five response plans for managing risks
  • Create a common risks checklist
  • Describe the importance of risk monitoring and control

Topics & Content

  • The criticality of risk management
  • Risk management processes
  • Risk identification methods
  • Pre-Mortem technique
  • Scenario planning
  • Common risk checklists
  • Risk impact analysis
  • Probability analysis
  • Probability-Impact analysis
  • Identify and manage risks for your projects - small group exercise

Course Information

Course Code: PM601
Duration: 1 day
Targeted Audience: Project managers, clinical trial managers and individuals responsible for risk management

  • CBRN - 7 CEU(s)
  • PMI - 7 PDU(s)

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