Drug Development and Life Cycle Management
Explore the Drug Development and Life Cycle 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.
Approved by the Regulatory Affairs Professionals Society for 6 RAC credits.
*15% off promotion excludes the DIA Medial Affairs eLearning modules and program package.
- Phases of drug development and drug development regulations
- Functional areas involved in the drug development process
- Workflow for bringing a new drug to market
- Discovery activities
- Toxicology studies
- Drug substance production and drug product formulation activities
- Good Manufacturing and Laboratory Practices
- Use of biomarkers and surrogate markers
- Objectives of Phase 1 studies and regulatory submissions required for Phase 1 studies
- Key activities that need to be completed before First in Human clinical trials can begin
- Risk-return decisions involved in Phase 1 studies
- Key objectives and activities of Phase 2 studies and regulatory activities and decisions that occur during Phase 2 studies
- Risk-return decisions involved in Phase 2 studies
- Clinical study activities of Phase 3 studies and safety reporting requirements
- Regulatory review process in the US and Europe
- Components of the CTD
- Key objectives of Phase 4 studies
- Five stages of a product life cycle
- How to grow or maintain market share by capitalizing on product or patient characteristics