Faculty: Charles Paul | Code: PM356111
Project management is essential to drug development for several reasons:
Overall, project management is crucial to drug development, as it helps ensure that the project is completed on time, within budget, and with the necessary quality standards and regulatory compliance. It is essential for the success of the project and the eventual delivery of safe and effective drugs to patients.
WHY YOU SHOULD ATTEND:
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.
LEARNING OBJECTIVES:
AREAS COVERED IN THE SESSION:
WHO SHOULD ATTEND:
Any member of a cross functional project team:
This course crosses all industries and functions it is however particularly suited for the health sciences and other regulated industries where much project-based work is accomplished. The types of industries that are targeted include:
TOPIC BACKGROUND:
The drug development process is a complex and highly regulated process that involves various stages, including discovery, pre-clinical development, clinical development, regulatory submission, and post-marketing surveillance.
In the discovery stage, project management involves coordination of research efforts and identification of potential drug candidates.
During pre-clinical development, project management involves planning and execution of studies to assess the safety and efficacy of the drug candidate.
In the clinical development stage, project management involves planning and execution of clinical trials to evaluate the safety and efficacy of the drug candidate in humans.
During regulatory submission, project management involves preparation and submission of regulatory documents to gain approval for the drug candidate.
In the post-marketing surveillance stage, project management involves ongoing monitoring of the safety and efficacy of the drug in the market.
Effective project management is critical to the success of drug development projects. The project manager must be able to coordinate cross-functional teams, plan and monitor timelines, manage risks, ensure regulatory compliance, manage budgets, communicate effectively with stakeholders, and continuously improve processes to ensure that the drug is developed safely and effectively.
Charles Paul is an instructional designer and management consultant with over 30 years experience providing training and consulting services to regulated industries. He has installed quality systems and designed and developed GMP and operational documentation and training programs for foods and beverage, pharmaceuticals, biotech, cosmetics, and consumer product OTC industries. |