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2-Day Course
Strategic Project Management for Clinical Development

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To remain competitive, pharmaceutical and biotechnology companies must continually pursue innovative products. Successful completion of innovative clinical trials is essential for product registration. Furthermore, clinical trial testing can bring novel medicines to the markets that meet unmet medical needs. These trials require huge investments of time and resources — with no guarantee of success. Efficient and effective management clinical trials can significantly impact resources for the development of a drug or device. Using Project Management processes and skills, the challenges inherent with strategic clinical development will be addressed. Both practical as well as tactical strategies will be presented.

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Course Outline

1. Regulatory Compliance

• GCP guidelines and FDA regulations.
• Efficiently plan and manage the quality of a complex clinical trial

2. Selection, managing and working with Contract Research Organizations (CRO’s)

• Develop the skills to successfully manage strategic partners, CRO’s and other support organizations
• Identify and manage outsourcing aspects of the project
• Strategic Alliance Management

3. Clinical Project Management Processes

• Produce the development schedule; the key to success
• Manage, monitor and control clinical trial timelines and budgets
• Prepare, plan and manage the product licensing submission

4. Transition phases and development milestones

• Managing development milestones
• Define, plan, manage and verify the scope of a clinical trial, estimate the resource needs and sequencing activities to produce a project schedule
• Planning for transition from phase to phase
• Identify the processes required to successfully plan, execute, monitor and control as well as close-out a complex clinical trial

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Immediate Benefits of This Course

• Improve your ability to plan, implement, monitor and control clinical development projects
• Lead and manage a team through the stages of clinical investigation to prepare the team to develop a transition strategy to move into next phase of clinical investigation
• Learn how to track, report and resolve issues, proactively evaluate project activities, build contingency plans, execute corrective actions and develop risk mitigation plans
• Develop effective tools to maximize efficiencies, deliver on targets and milestones and demonstrate the strategic advantage of the project management function to the organization at large

 

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Who should attend

• Clinical Project Managers
• Clinical operations personnel
• Clinical Research Associates
• Clinical Study Coordinators
• Project Managers, Directors and Leaders
• Clinical Investigators
• Clinical Trial Managers, Monitors and Associates
• Pharmacovigilance Professionals
• Drug Labeling Professionals
• Physicians and Medical Liaisons
• Regulatory Affairs Professionals
• Preclinical Development Professionals
• Research and Development Scientists