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					                       Objectives
   Understand     the     difference
    between a project and project
    management
   Develop a working knowledge of
    how to properly scope a project
    for success
   Schedule project activities using
    a Gantt chart
             What is a Project?
A project is a sequence of unique,
 complex, and connected activities
 having one goal or purpose and that
 must be completed by a specific time,
 within budget, and according to
 specifications.
What is Project Management?
Project management is a set    of
principles and tools for
      Defining
      Planning
      Executing
      Controlling . . . and
      Completing a PROJECT
    Project Management Criteria
   Projects are oriented towards a goal
   There is something unique about
    every project.
   Projects have a finite duration.
   Projects require coordination of
    interrelated activities.
    What is Project Cycle ?

    Project identification
    Project formation
    Appraisal
    Implementation
    Monitoring
    Plan revision
    Evaluation
    Feedback
Project Cycle Management


Evaluation           Plan
  (See)            (Idea)
             PDM



 Implementation (Do)
             Project manager
A project manager is a professional in the
field of project management. Project
managers can have the responsibility of the
planning, execution, and closing of any
project
                       Responsibilities
The specific responsibilities of the Project
Manager vary depending on the industry,
the company size, the company maturity,
and the company culture.
 Developing the project plan
 Managing the project stakeholders
 Managing the project team
 Managing the project risk
 Managing the project schedule
 Managing the project budget
 Managing the project conflicts
 Work plan / Plan of Operations
The Plan of Operation is prepared by the
project implementers, based on the PDM and
other information. It is an effective tool for
project implementation and management,
and provides important data for monitoring
and evaluation of the project.
       A PROJECT IS...




SPECIFICATIONS
 (QUALITY AND
   QUANTITY)
                     INTERNAL FORCES
       Evaluation     Team
                                Turf

   Quality


               YOUR
                                  Strategic
              PROJECT
Time                               Intent




   Decision
   Making                  Marketing


               Selection
                EXTERNAL FORCES
                  Commercial
  Competition      Potential

Time
           YOUR
          PROJECT          FDA



  Activists
                    Congress


       Reimbursement
Top Drug Costs
                      Project
                     Planning
                        3%          Site
                                 Management
     Site                           30%
   Payments
     48%

                                   Data
                                Management
                                & Statistics
                  Safety &         11%
       Pharmacy     CEC
          5%        3%
                                                  Populati
Bench                  Patients
                                                    on




        First block:                Second
                                    block:
        Translation
            from                   Translation
        concept into              from clinical
        first human                 trials into
           studies                   practice
Critical Path Method (CPM)
 CPM is a network diagramming technique
  used to predict total project duration.
 A critical path for a project is the series of
  activities that determines the earliest time
  by which the project can be completed.
 The critical path is the longest path through
  the network diagram and has the least
  amount of slack or float.
 Slack or float is the amount of time an
  activity can be delayed without delaying a
  succeeding activity or the project finish date.


                                        18
              Calculating the Critical Path
 Develop a good network diagram.

 Add the duration estimates for all activities
  on each path through the network diagram.

 The longest path is the critical path.

 If one or more of the activities on the
  critical path takes longer than planned, the
  whole project schedule will slip unless the
  project manager takes corrective action.




                                           19
The Critical Path for Medical Product
Development
Working in Three Dimensions on
               The Critical Path
Discovery                                                                                  Translation
                        Translation                          Clinical                                                          Global
                                                            Research                      and Adoption                         Health


                                                                                                                                         Global
                                                                          FDA Approval     Practice        Community
  Basic         Preclinical                Proof of                                                                         Improve      Health:
                                                            Clinical                      Adoption,        Assessment
Discovery       Research;       PK,PD,     Concept                                                                         Community     Service/
                                                         Development       Evidence        Practice       •Care delivery
                 In Vivo      Toxicology   in Man                                                                            Health     Research,
                                                          Phase II, III     Based         Guidelines,      •Outcomes
                 Analysis                                                                                                    Status    Population/
                                                                           Medicine      Cost Effective    •Economics
                                                                                                                                       Publication




                                            Current State Entities


AHS/Industry/                                          Clinical Research                      HCS/Hospitals/   Public Health/Government/
                   Industry/Biotech
  Biotech                                             Organizations/AHS                     Practices/FQHC/AHS            NGOs




                                                            Timeline

                                  15-20 years                                                                   ?
ACKNOWLEOEDGEMENT




      REFERENCES

				
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posted:2/5/2010
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