Drug and device development is a complex process which needs effective project management. With ever-increasing pressures in the industry, the use of project management can provide essential tools and techniques and be a key factor in the successful completion of bringing a drug or medical device to market - as demonstrated by the FDA critical path initiative.
This interactive two-day course has been designed to provide you with a thorough understanding of both technical and interpersonal project management skills.
Interactive exercises are used to aid the learner in the application of project management concepts and principles so they can easily use the tools to improve the success of existing or future pharmaceutical projects.
The programme will include a number of sessions where you will be able to apply some of the techniques to a simulated pharmaceutical case study as well as your own projects. You are therefore encouraged to bring a real project you are currently involved in or will be working on to which you can apply some of the concepts and techniques. There is no need to disclose any confidential information about your project.
Benefits of attending:
- Acquire an in-depth understanding of technical project management methodologies and techniques to apply to pharma/bio projects, including agile project management
- Learn how to incorporate these project management processes into everyday working practices and your current projects
- Understand how to blend together both the technical aspects of project management and the essential interpersonal skills
- Discover how to build core competencies to become an even more effective project manager
- Discuss how to get the best results in a project team environment
Aims and objectives
The objective of this course is to ensure you gain a comprehensive understanding of the tools and techniques of project management and discover how they can be applied straight away to your own pharma/bio or medical device projects. The programme has been specially designed to ensure that you:
- Understand technical project management tools and techniques and can apply these to your work
- Examine the competencies appropriate for an effective project manager
- Identify the project critical path and use this information to assist in planning decisions
- Gain a better understanding of the essential personal skills which are necessary to achieve project objectives
Certifications:
- CPD: 12 hours for your records
- Certificate of completion
Agenda
Day 1
What is a project/project management in the pharma/bio industry?
- Defining the key characteristics of project management and their importance to the bio/pharma industry
- Using a project management process for improving the success of your own projects, including agile project management
- Sharing experiences and lessons learned from previous bio/pharma projects
Setting clear project objectives and defining the scope of pharma/bio projects
- Aligning the project objectives with the strategic and financial business objectives
- Defining the result, the cost and the time
- Understanding the importance of having an overall strategy for your projects
Detailed project planning of pharma/bio projects
- Identifying the key project activities using a Work Breakdown Structure (WBS)
- Allocate responsibilities using the responsibility matrix
- Planning a realistic schedule using Gantt analysis and setting clear milestones
- Budget planning, communication plan, quality plan
- Implementing risk management and contingency planning for your project
- Experiences of project management software and tracking systems
Project implementation and control for your projects
- Identifying the possible causes of problems in pharma/bio projects
- Effective communication and how to manage stakeholders
- Overcoming enablers and constraints of your projects
- Implementing project control and reporting systems
- Monitoring project activities and performance
Day 2
Project review and closure
- Close the project
- Identifying the critical success factors and learning from mistakes
Pharma/bio leadership skills
- Defining the role and skills of effective pharma project leaders
- Improving your interpersonal skills as a leader
Motivate to achieve project milestones
- Understand how to motivate different people and what motivates your project team
- Completion of a self-evaluation questionnaire
Building pharma/bio project teams
- How to modify your leadership style to get the best results in a project team environment
- Building a high performance team
Project communication and cross-cultural communication skills
- Effective communication and how to gain project buy-in
- Preventing and overcoming misunderstandings and dealing with conflict
- Communicating effectively with the project stakeholders including cross-culturally
Project time management
Speakers
Dr Laura Brown,
Pharmaceutical QA and Training Consultant ,
University of CardiffDr Laura Brown MBA, BSc,PhD, is a Pharmaceutical QA and Training Consultant, Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. She has more than 20 years’ experience of quality assurance in the pharmaceutical industry and has worked for several companies, including GSKs Hoechst Marion Roussel, Farmitalia and Phoenix International. She has a particular expertise in quality assurance including risked based approaches to quality systems, data Integrity and project management in the pharmaceutical industry. She regularly writes on pharmaceutical regulatory issues including “The Planning of International Drug Development”, in the Clinical Research Manual, Euromed and the “Impact of Brexit”, RQA Journal 2017.
Who Should Attend
- This course has been specifically designed to address the needs of pharma/bio professionals as well as those in the medical device and animal health industries.
- The programme will benefit both newly appointed and established project team leaders/managers wishing to refresh or update their skills.
