The leading project management course designed specifically for the bio/pharma Industry - also applicable to those in medical device and animal health industries.
Drug and device development is a complex process which needs effective project management. With ever increasing pressures to complete the development of drugs and medical devices in ever shorter timescales, the use of project management can provide essential tools and techniques to achieve this. Indeed effective project management can be a key factor to successful completion of bringing a drug or medical device to market – as demonstrated by the FDA critical path initiative.
This interactive course has been designed to provide you with a thorough understanding of project management skills, including both technical and interpersonal skills. You will be provided with an integrated project tool kit which can easily be used to improve the success of existing or future projects.
Interactive sessions applying techniques to a simulated case study and your own projects The course 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.
Therefore, you are encouraged to bring a current real project you are 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.
Why you should attend
This interactive course will:
- Provide you with an In-depth Understanding of Project Management Tools and Techniques to Use in the Bio/Pharma Industry
- Enable you to Incorporate the Project Management Processes into Everyday Working Practices and in your Current Projects
- Understand How to Blend Together Both the Technical Aspects of Project Management and the Essential Interpersonal Skills
- Examine the Competencies Appropriate for an Effective Project Manager
- Share Best Practice Project Management Approaches
- Discuss How to get the Best Results in a Project Team Environment
Programme Day One
What is a Project / Project Management in the Bio/Pharma 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
- Sharing experiences and lessons learned from previous bio/pharma projects
Setting Clear Project Objectives and Defining the Scope of Bio/Pharma 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 Bio/pharma 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 bio/pharmaceutical 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
Programme Day Two
Project Implementation and Control Continued
Project Review and Closure
Close the project
- Identifying the critical success factors and learning from mistakes
Bio/Pharma 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 Bio/Pharma 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
- Identifying and managing common time wasting activities in your projects
- Maximising your prime time to improve your personal performance
Personal Action Planning
Dr Laura Brown,
Pharmaceutical Management and Training Consultant ,
University of Cardiff
Dr Laura Brown MBA, BSc (Biochemistry), BSc (Psychology), PhD, Diploma in Clinical Science, FICR, is a Pharmaceutical Management and Training Consultant, Course Director for the MSc in Clinical Research at the University of Cardiff, and MSc Regulatory Affairs, TOPRA.
She has more than 19 years experience in the pharmaceutical industry and has worked for several companies, including GlaxoWellcome, Hoechst Marion Roussel, Farmitalia and Phoenix International. She has worked in Drug Development, Clinical Research, Quality Assurance and Marketing. Laura has a particular expertise in Clinical Research and GCP issues. She was Chairman of the ACRPI GCP Forum for six years. She regularly writes on clinical research issues and ICH GCP, is author of SCRIP’s GCP guide and is a member of the editorial board of the Board of the Good Clinical Practice Journal. In addition to her scientific qualifications, she has a degree in psychology and an MBA.
Laura is co-author of several books on management including Developing the Individual, The Ultimate Book of Business Skills and Pharmaceutical Project Management.
- Drug or Device Development
- Project Management
- Project Management Office
- Clinical Research/Clinical Operations/Clinical Trials
- Medical Affairs
- Quality Assurance
- Regulatory Affairs
- Data Management
- Pre-Clinical Development
- Study Sites
- Research Institutions and academic research
- Regulatory Authorities
Venue to be announced shortly.