projeat_rj_cliniminds

8/9/2019 projeat_rj_cliniminds

1/25


2/25

Objectives

Understand the differencebetween a project and project

management

Develop a working knowledge of

how to properly scope a projectfor success

Schedule project activities using

a Gantt chart


3/25

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 tospecifications.


4/25

What is Project Management?

Project management is a set ofprinciples and tools for

Defining

Planning

Executing Controlling . . . and

Completing a PROJECT


5/25

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.


6/25

What is Project Cycle ?

Project identification

Project formation

Appraisal

Implementation

Monitoring Plan revision

Evaluation

Feedback


7/25

Project Cycle Management

Plan

(Idea)

Implementation (Do)

Evaluation

(See)

PDM


8/25

Project manager

A project manager is a professional in thefield of project management. Project

managers can have the responsibility of the

planning, execution, and closing of any

project


9/25

ResponsibilitiesThe 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 teamManaging the project risk

Managing the project schedule

Managing the project budget

Managing the project conflicts


10/25

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.

Work plan / Plan of Operations


11/25

A PROJECT IS...

SPECIFICATIONS(QUALITY AND

QUANTITY)


12/25

INTERNAL FORCESTeam

Turf

StrategicIntent

Marketing

Selection

Decision

Making

Time

Quality

Evaluation

YOURPROJECT


13/25

EXTERNAL FORCES

Commercial

Potential

FDA

Congress

Reimbursement

Activists

Time

Competition

YOURPROJECT


14/25


15/25

Top Drug Costs

Pharmacy

5%

Data

Management

& Statistics

11%

SiteManagement

30%Site

Payments

48%

Safety &CEC

3%

Project

Planning

3%


16/25


17/25

Bench PatientsPopulati

on

First block:

Translationfrom

concept into

first humanstudies

Secondblock:

Translationfrom clinical

trials intopractice


18/25

18

Critical Path Method (CPM)

CPM is a network diagramming techniqueused 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 ofslack or float.

Slack or float is the amount of time anactivity can be delayed without delaying a

succeeding activity or the project finish date.


19/25

19

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.


20/25

The Critical Path for Medical Product

Development


21/25

Working in Three Dimensions on

The Critical Path


22/25

asic

covery

PreclinicalResearch;

In Vivo

Analysis

Clinical

Development

Phase II, III

Translation

FDA Approval

Evidence

Based

Medicine

Clinical

Research

PracticeAdoption,

Practice

Guidelines,

Cost Effective

CommunityAssessment

Care delivery

Outcomes

Economics

Translation

and Adoption

ImproveCommunity

Health

Status

Global

HealthService

Researc

Populatio

Publicati

Global

Health

Current State Entities

Industry/BiotechClinical Research

Organizations/AHS

HCS/Hospitals/

Practices/FQHC/AHS

Public Health/Governm

NGOs

scovery

/Industry/

Biotech

15-20 years ?

Timeline

PK,PD,

Toxicology

Proof of

Concept

in Man


23/25

REFERENCES

ACKNOWLEOEDGEMENT


24/25


25/25

projeat_rj_cliniminds

Documents

Transcript of projeat_rj_cliniminds