Project Management in. Pharmaceutical Industry

Project Management in Pharmaceutical Industry BARCELONA, MARCH 11th, 2015 Mireia Pladevall What is a Project  A project is a unique and scheduled...
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Project Management in Pharmaceutical Industry BARCELONA, MARCH 11th, 2015 Mireia Pladevall

What is a Project 

A project is a unique and scheduled effort, with the aim to produce specific objective within a limits of time, cost and quality previously defined and agreed.

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What is a Project  Classical triple restriction of Projects:

All Projects has de following things in common: –  Goal oriented –  Activities are coordinated and inter-related –  Finite duration –  Uniqueness GALENICUM – MIREIA PLADEVALL– PROJECT MANAGEMENT IN PHARMA 3

Project Management in Pharmaceutical Industry

Not implemented as other sectors like IT, construction and automotive But… –  –  –  –  –  – 

R&D PM’s : Development of NCE, OTC and Generics Clinical PM’s Technical Transfer PM’s Launch PM’s Life Cycle PM’s Strategic PM’s

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Project Management in Pharmaceutical Industry

But why are PM’s in Pharmaceutical Industry: –  Resources are limited –  Time to market is critical –  Drug development has inherent uncertainty and difficulties –  Environment high regulated with high quality standards

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What phase of Development PM’s applies ?

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Project Management in Pharmaceutical Industry

What Project Managers do: –  Cost – effective planning, execution and monitoring of the projects –  Faster project procedure –  Ensure that all phases are running correctly and there is transition between them –  Ensure that project meets with stakeholder objectives

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Projects Selection in R&D Pharma

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Project Management Phases 

Initiating

Planning

Executing

Monitoring / Controlling

Closing

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Project Management phases - Planning

Project Plan –  –  –  –  –  –  –  – 

Definition of project scope and goals Schedule Quality management Resources Stakeholders management Communication management Risk management Budget

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Project Plan 

WBS

–  Work Breakdown Structure can be used to effectively decompose the project scope, to improve estimating, to better control the project execution and to more accurately verify project completion

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Project planning - WBS Development Generic Drug

Project Preparation

Project Charter

Pharmaceutical Development De evelopment Analytical Development

Exhibit Batches B

Stability

BE

Dossier

Materials M Procurement Pro P

Protocol

CRO selection

Dossier Preparation

Tech. Transfer

t=0

Bio Batch selection

Dossier Submission

Manufacturing

t=6m

Experimental phase

API study

Project Plan

Set up of Methods Validation

Project Approval Ph Pharmaceutical harmaceutical D Development Kick-off

Reg. Product Charac.

Batch Analysis

Result

Prototype Definition

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Project Planning - Gantt

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Life cycle of a Project  LC is the different phases that constitute a project

–  Activities •  Objectives •  Duties (Duration and resources) •  Responsible

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Project Management phases - Control and reporting

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Closing

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Closing 

Closing Report –  At the completion of the project a Project closing report should be written –  It should summarize processes, findings, budgets constraints and specific lessons learned from the project

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Project Manager Competences

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How to access to PM’s vacancy 

Solid technical knowledge and background in pharmaceutical industry Complemented with specific formation in Project Manager –  Several Masters in the market

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Job offers

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Job offers

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Would you like to be a PM?

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