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
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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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