Project management The basics

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1 Training programme in pharmaceutical medicine Project management The basics life cycle, organization and processes 10 mar - 12 mar 2011

2 Project management The basics life cycle, organization and processes 10 March 12 March 2011 LocaL: University of Aveiro, Campus Universitário de Santiago curricular unit Leader: Francisco rocha Gonçalves, Phd Lecturers: Francisco Rocha Gonçalves,,. organisation: Mestrado em Biomedicina Farmacêutica (Masters in Pharmaceutical Biomedicine) curso de especialização em Medicina Farmacêutica de Longa duração (Post-Graduate Course in Pharmaceutical Medicine) Director: Luis Almeida, MD, PhD, FFPM Deputy Director: Bruno Gago, PharmD, PhD ua.pt) address: Secção Autónoma de Ciências da Saúde (SACS) Universidade de Aveiro Campus Universitário de Santiago Edifício III Aveiro Portugal Tel Fax

3 Day MARCh time Programe Lecturer 09h00-09h30 0. introduction Francisco Rocha Gonçalves (UA) 1. Project Management - Process & roles 09h30-10h00 10h00-10h30 10h30-11h30 11h30-12h30 12h30-12h45 12h45-14h Objectives Project Management Process Terms: Project, Sub-Project, Programs, Portfolios, Operations, Project Management Office, Stakeholder Project Life Cycle: Life Cycle Models (Initiating, Planning, Executing, Monitoring/Controlling, Closuring); Cost of Correction; Project Management Factors; Issue - Governance (Project Manager, Project Stakeholder, Project Sponsor, Project Team); Issue - Phases; Issue - Project Culture & Style; Life Cycle Processes Knowledge Area: Integration, Cost, Communications, Scope, Quality, Risk, Time, Human Resource, Procurement Summary. (Lunch) 14h00-14h30 14h30-16h30 16h30-17h00 17h00-17h30 2. Project initiation 2.1. Introduction: Definitions (Project, Program, Portfolio); Relationships Project Initiation: Selection Processes; Project Statement of Work; Statement of Work - Exercise: Project Proposal; Review of Project Proposal Exercise: Business Need, Scope Description, Strategic Plan Linkage, Business Case; Project Charter; Stakeholder Identification Project Planning - Small Group Prep Work Preparation for Day 2 & Summary.

4 Day MARCh time Programe Lecturer 2. Project Management - Planning for Success 09h00-09h30 09h30-10h00 10h00-10h30 10h30-11h00 11h00-11h30 11h30-12h00 12h00-12h30 12h30-14h00 14h00-14h30 14h30-15h00 15h00-15h30 15h30-16h00 16h00-16h30 16h30-17h Introduction Communications: Group Presentation, Lecture & Discussion, Clinical Research Issues Work Breakdown Structure: Group Presentation, Lecture & Discussion, Clinical Research Issues Schedule - Task Relations and/or GANTT Chart: Group Presentation, Lecture & Discussion, Clinical Research Issues Schedule - PERT Chart & Critical Path: Lecture & Discussion, Clinical Research Issues Communications: Group Presentation, Lecture & Discussion, Clinical Research Issues Review of Morning. (Lunch) 3.8. Risk: Group Presentation, Lecture & Discussion, Clinical Research Issues Launch: Group Presentation, Lecture & Discussion, Clinical Research Issues Change (Adaption & Control): Group Presentation, Lecture & Discussion, Clinical Research Issues Staffing (People Plan): Group Presentation, Lecture & Discussion, Clinical Research Issues Close Out: Lecture & Discussion, Clinical Research Issues Summary.

5 Day MARCh time Programe Lecturer 4. Project execution in clinical research 09h00-09h30 09h30-10h00 10h00-11h00 11h00-12h00 12h00-12h30 12h30-12h Introduction Roles and Responsibilities: for Pharma & Clinical Research Organizations under the International Conference on Harmonisation (ICH); Good Clinical Practice (ICH-GCP) Clinical Research Project - Work Areas: Project Management; Regulatory; Clinical Monitoring; Medical Monitoring; Data Management; Pharmacovigilance; Analysis and Reporting Terms Project Execution in International Teams: Cross-Cultural Awareness; Communications; Time & Distance Financial Control in Shared Teams Summary. 12h45-14h00 14h00-14h15 14h15-14h30 14h30-15h00 15h00-16h30 16h30-17h00 (Lunch) 5. Project team Management 5.1. Introduction Project Manager s Professional Responsibilities Project Manager s Interpersonal Skills: Leadership; Team Building; Motivation (and Rewards); Communication; Influencing (and Modeling); Decision Making (and Initiation); Cultural Awareness; Negotiations Project Team (Cross-Team): Lecture; Exercise; Discussion Course Summary.

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