Project Management for Non-Project Managers - Project Management in Drug Development
It is important for a project manager to understand how the project management process integrates into drug development because drug development is a complex and highly regulated process that involves various stages, including discovery, pre-clinical development, clinical development, regulatory submission, and post-marketing surveillance.
Effective project management is critical to ensure that the drug development process runs smoothly and efficiently and that the drug is developed in compliance with regulatory requirements.
Understanding how the project management process integrates into drug development is critical to the success of drug development projects. A project manager who understands the unique challenges and requirements of drug development can help ensure that the project is completed on time, within budget, and in compliance with regulatory requirements, ultimately leading to the development of safe and effective drugs for patients.
Why Should You Attend:
Project management is essential to drug development for several reasons:
- Resource allocation: Drug development is a complex process that involves multiple teams working on various stages of research, development, and regulatory approval. Effective project management helps ensure that resources, including time, money, and personnel, are allocated efficiently to meet the project's objectives
- Collaboration: Drug development requires collaboration among researchers, clinicians, regulatory agencies, and stakeholders. Effective project management ensures that all parties are aligned on the project's goals, timelines, and milestones and that communication channels are established to facilitate collaboration
- Risk management: Drug development involves a high degree of uncertainty, as many projects fail to reach approval due to safety or efficacy concerns. Effective project management can help identify potential risks and establish contingency plans to mitigate them
- Regulatory compliance: The drug development process is heavily regulated, and regulatory compliance is critical to obtaining approval for a drug. Effective project management can help ensure that all regulatory requirements are met and that the necessary documentation is completed and submitted in a timely manner
- Time-to-market: Drug development is a lengthy process that can take many years to complete. Effective project management can help reduce the time-to-market by streamlining processes, identifying bottlenecks, and implementing strategies to accelerate development
Learning Objectives:
- Define the drug development process
- Explain how the drug development process integrates into the project management process
- Explain how regulatory compliance integrates into drug development
- Define the critical project management processes as they relate to drug development
Areas Covered in the Session:
- Drug development process
- Integration of the drug development process and the project management process
- Cross-functional team coordination
- Timelines and milestones
- Risk management
- Regulatory compliance
- Budget management
- Communication and stakeholder management
- Technology and data management
- Quality management
- Continuous improvement
Who Will Benefit:
- Engineering
- Research & Development
- Technical Services
- Supply Chain
- Regulatory Compliance
- Operations
He has held senior positions in consulting and in corporate training development prior to forming C. H. Paul Consulting, Inc. He also worked for several years in government contracting managing the development of significant Army-wide training development contracts impacting virtually all of the active Army and changing the training paradigm throughout the military.
He has dedicated his entire professional career explaining the benefits of performance-based training