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PM Milestone Project Management Templates

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Due to the complexity of the drug development plan overall and the conduct of each clinical trial, effective management (and leadership) of the project team is important to ensure that quality is maintained throughout and the timelines are met. This team includes representatives from all the departments that will be meeting team objectives and performing work in the plan. A typical project team may include individuals from the disciplines outlined on Fig. 8.10. The project team will work in their respective areas to complete the product profile, package insert, and the development plan. The team members should serve three roles: representing their departments on the team as communicators/liaison, performing the work with colleagues from their area, and decision makers within the team. Research groups, such as chemistry, pharmacology, and toxicology, are represented on the clinical project team to provide input from their research or follow-up on issues discovered r Due to complexity of drug development & conduct of clinical trials, project management ensures that quality & timelines are met. r Project team typically includes variety of functional groups with responsibilities for Development Plan and conduct of clinical trials:

o Project management o Clinical research o Regulatory o Pharmacology & Toxicology o Chemistry, pharmaceutics and manufacturing o Safety group o Marketing c Biostatistics c Data management

Fig. 8.10. Project Management and Project Team

Once development plan is created, clinical planning process may begin.

This involves significant amount of management and planning in itself.

Clinical plan is description of timelines associated with clinical trials and includes additional detail not provided in development plan.

Phase 1.2 Trial [Safety/Efficacy in Patients]

Phase 2.x Special Trials [Safety/Efficacy Evaluation: Patients]

Phase 1.2 Trial [Safety/Efficacy in Patients]

Phase 2.x Special Trials [Safety/Efficacy Evaluation: Patients]

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Project Management Made Easy

Project Management Made Easy

What you need to know about… Project Management Made Easy! Project management consists of more than just a large building project and can encompass small projects as well. No matter what the size of your project, you need to have some sort of project management. How you manage your project has everything to do with its outcome.

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