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