Project Management in Medicines Development: Theory and Practice
Planned for Spring 2018
University of Basel, Advances Studies, Steinengraben 22, 4051 Basel
Due to the ever increasing pressure on bringing a new medicine on the market, these projects are getting more time consuming, expensive, and complex. Using proven project management approaches, organisations and individuals responsible for these projects will be supported to minimising the risks associated to these projects in terms of quality issues, budget overruns, as well as exceeding the timelines.
This course will focus on theoretical and practical aspects of project management. Using a clinical trial as sample project all templates and tools for planning, executing, managing & controlling and closing a project will be developed. Examples and exercises working on computer will guide the participants through the practical implementation of project management. This course has a workshop character and is therefore highly interactive. Discussing scenarios from real-world projects, and adjusting tools and templates to accommodate these, will ensure that the participants understand the logic behind the tools and can adapt them to the specific needs of their individual projects.
- This course focuses on the principles of PMBoK, (Project Management Body of Knowledge v5 – ANSI 99-001-2013) to reflect not only the general concepts of project management but also the specific aspects of pharmaceutical projects (incl. development cycle of a medicinal molecule or the management of clinical trials).
- Participants will learn to fully understand the principles of project management and to refer to PMBoK as a guide
- All project phases (initiation, planning, execution, monitoring & controlling, closure) as well as knowledge areas (management of scope, time, cost, quality, team, communication, risk, procurement, stakeholders) will be discussed, using examples from pharmaceutical development projects.
- Starting from a project charter, a project plan will be developed and documents and worksheets for managing clinical trials or other projects relating to pharmaceutical development will be created
- Participants will learn how to make the most effective use of these documents by implementing tracking and reporting features.
- Key Performance Indicators to judge the status of the project as well as CAPAs to prevent the project from getting off track will be discussed.
At the end of the course, participants will
- understand the tasks and responsibilities of a project manager
- know the major project documents required for successfully conducting projects
- be acquainted with the tools to manage all knowledge areas throughout all project phases and with the interactions needed with different project stakeholders
- how to practically apply the PMBoK (Project Management Body of Knowledge) project management standard to pharmaceutical development projects
- know how to use a series of templates and tools, and be able to adapt these for the use with their individual projects
This course is organised by the European Center of Pharmaceutical Medicine, University of Basel in collaboration with the CTU Clinical Trial Unit, University Hospital Basel, dkf.unibas.ch