Drug Development and Lifecycle Management eLearning Program
Understand how companies structure their efforts and utilize their resources to improve the odds of successful development, and potentially minimize the risks associated with shepherding a new drug candidate through the development process. Upon completion, you will be able to explain the phases, major work streams, key players and interrelationships necessary to develop new drugs in the US and Europe, and to expand the life cycle of in-line products.
The online program includes six self-paced modules that can be accessed 24 hours a day, 7 days a week. Modules do not have to be taken in one sitting; users can start/stop at any time and begin where they left off. Users will have one year to complete the modules and continuing education credits are offered.
Learn the activities required to move a drug candidate from idea to the market, and how various functional areas are organized and contribute at each stage of development. Learn about the regulatory environment in which these activities occur.
Examine the activities associated with phase 1 developnment, with a focus on the drivers that impact the design of the first-in-human study.
Learn the factors that drive the design and conduct of phase 2 clinical trials, as well as the activities and functional areas that contribute to a successful phase 2 program.
Review phase 3 clinical study activities and the regulatory requirements and components of an application for marketing approval in the US and EU.
Review activities associated with the management of a marketed drug, as well as focus on how companies maximize the value of approved products through the lifecycle management process.
Explore the fundamentals of why and how to incorporate patient focus and build organization-wide capabilities.
Learn how labeling is developed and maintained throughout the product’s marketed life and the components and structure of prescription labeling.