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2-Day Course
Managing and Mitigating Risk in Pharmaceutical Development Projects

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We all recognize that risk and uncertainty is an inevitable part of all projects. Do we aggressively plan and prepare to manage and mitigate pharma development risks or do we deny that they will happen? Risk management is generally ignored or certainly addressed only when it happens. What are the potential upsides and downsides of our development projects and how can we initiate a total Risk Management system in our projects? There are many approaches and processes that can be developed for risk evaluation. How do we organize our projects and plan for Project Risk?

The participant will learn both practical as well as tactical strategies to plan, manage and mitigate pharmaceutical development risk and reveal strategies using Project Management processes and skills to address the challenges inherent with Risk Management will be addressed.

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Course Outline

1. Quantitative Risk Management

• Develop a risk evaluation strategy
• Common sources of project risk
• Creating Ishikawa diagrams to analyze cause and effect relationships
• Utilizing checklists
• Assessing high-level risks to the organization
• Performing probability and impact analyses of identified risk

2. Risk Management Plan: Garbage in-Garbage out

• How to plan to mitigate project risk
• Develop a project level risk management plan
• Using your team to identify and document risks that can affect the project
• Perform a qualitative risk analysis
• Develop a model to complete a quantitative risk analysis
• Determine what actions need to be implements to mitigate risk
• Develop a control process to monitor risk

3. Risk Response Planning

• Learn how to determine the actions necessary to take to reduce the likelihood of negative effects on the project’s objectives
• Learn how to quantify risk
• Learn how to describe the actions to be taken to mitigate the risk

4. How to build a project plan to avoid risk?

• Developing clear, agreed-upon objectives and timelines with your team
• Understanding the roles, responsibilities and expectations of teams
• The use of project checklists and work sheets
• How to bridge cross-cultural gaps and challenges
• Creating effective communication processes
• Maximizing value while managing risk

5. Risk Impact

• Understanding the customer’s needs
• Identifying the customers strategy
• Assessing the customer view of an alliance
• Risk Response Planning
• Implementing risk response strategies
• Accept
• Avoid
• Transfer
• Mitigate
• Exploit
• Share
• Enhance

6. Change Control

• Ensuring there is an effective change control process in place
• Developing a reliable change request and approval process
• Recommendations for corrective action

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Who Should Attend

• Project Managers
• Project Directors and Leaders
• Development Project Managers
• Program Managers
• Business development managers