training programme in pharmaceutical medicine PROJECT MANAGEMENT- PROCESS & ROLES

Transcription

1 training programme in pharmaceutical medicine PROJECT MANAGEMENT- PROCESS & ROLES Auditorium GlaxoSmithKline Arquiparque, Miraflores, Algés, Lisbon, Portugal october 2011

2 Project management- PROCESS & ROLES october 2011 LOCAL: Auditorium GlaxoSmithKline, R. Dr. Ant.º Loureiro Lopes, 3 Arquiparque, Miraflores, Algés, Lisbon CurriCuLAr unit LeAder: Francisco rocha Gonçalves, Phd Lecturers: Sandra Lang, Language: Full programme in English Organisation: Masters in Pharmaceutical Medicine Post-Graduate Course in Pharmaceutical Medicine Director: Luis Almeida, MD, PhD, FFPM (l.almeida@ua.pt) Deputy Director: Bruno Gago, PharmD, PhD (bmgago@ ua.pt) Address: Health Sciences Department University of Aveiro Campus Universitário de Santiago Edifício III Aveiro Portugal Tel Fax cs.secretaria@ua.pt

3 DAy OCTOBER time Programe Lecturer 09h00-09h Introductions Agenda Morning; Presenters; Students. Francisco Rocha Gonçalves (UA) 09h30-10h Introductions - Syllabus course. 10h00-10h Project Management Process 10h30-11h15 11h15-11h45 11h45-12h00 12h00-14h00 14h00-14h15 14h15-14h30 14h30-14h45 14h45-15h00 15h00-15h30 15h30-16h00 16h00-16h15 16h15-16h30 16h30-17h terms: Project; Sub-Project; Programs; Portfolio; Operations; Project Management Office; Stakeholder Project Life Cycle: Life Cycle Models (Initiating; Planning; Executing; Monitoring/Controlling; Closing); 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 of the Morning (Lunch) 2.1. Introduction - Session Review Morning; Agenda Afternoon 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 2.4. Project Planning Small Group Prep Work Preparation for Day 2 & Summary of the Afternoon

4 DAy OCTOBER time Programe Lecturer 09h00-09h30 09h30-10h00 10h00-10h30 10h30-11h00 11h00-11h30 11h30-12h00 12h00-14h Introductions Review of Yesterday; Agenda of the Day; Final Preparation for Exercise team Players Exercise; Lecture & Discussion; Clinical Research Issues communications 3.4. Work breakdown Structure 3.5. Schedule task relations and/or GANtt chart 3.6. Schedule Pert chart & critical Path Lecture & Discussion; Clinical Research Issues. (Lunch) 14h00-14h review of Morning 14h15-14h risk 14h45-15h15 15h15-15h45 15h45-16h15 16h15-16h45 16h45-17h Launch change (Adaptation & control) Staffing (People Plan) close out Lecture & Discussion; Clinical Research Issues Summary of Afternoon

5 DAy OCTOBER time Programe Lecturer 09h00-09h15 09h15-09h45 09h45-10h45 10h45-11h45 11h45-12h15 12h15-12h30 12h30-14h00 14h00-14h15 14h15-14h30 14h30-15h00 15h00-16h30 16h30-17h Introduction Agenda for the Morning roles and responsibilities for Pharma & clinical research organizations under the International conference on Harmonisation - Good clinical Practice (IcH-GcP) 4.3. 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 4.6. Summary of the Morning (Lunch) 5.1. Introduction - Session Review Morning; Agenda Afternoon Project Manager s Professional responsibilities 5.3. Project Manager s Interpersonal Skills Leadership; Team Building; Motivation (and Rewards); Communication; Influencing (and Modeling); Decision Making (and Initiation); Cultural Awareness; Negotiations cross-functional teams Lecture; Exercise; Discussion course Summary

6 Module objectives: To teach the basic definitions and goals of project management processes and roles; To transmit how to successfully start a project, making sure that every task is accounted for and assigned to during pre-planning; To understand how and why to manage time, resources, and funding through tools and steps such as Work Breakdown Structures, Staffing, Communications, Stakeholders, Adaptation, and Closure; To apply the concepts of project management to the specifics of the Clinical Research Environment; To explore a project manager s responsibilities, the interpersonal skills, team management proficiencies, and Professional and Social Responsibilities. Learning outcomes of the Module: After module completion, the participant should be able to: Understand how strategic plans affect project selection; Apply the Harvard Business Essential s Project Management model to a given project; Understand the key elements of Project Management Body of Knowledge (PMBOK4 ); Understand the project management life cycle and phases: Initiating, Planning, Executing, Monitoring/Controlling, and Closing; Develop a project proposal; Apply the basic tools to plan a project; Create and review the tools for managing and controlling a project; Monitor and communicate project progress to stakeholders; Bring a project to closure and communicate results; Execute projects in the Clinical Research environment. Endorsed by the Associação de Médicos Portugueses da Indústria Farmacêutica