Drug Development eLearning Program
Drug development is an incredibly complex and risky endeavor, one that even experienced organizations will fail at more often than they succeed. This program will help you 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. At the end of the program, 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. These six modules will take approximately 6.5 hours to complete.
Credit Information
6.5 ACPE
7 IACET
6.5 PMI
7 IACET
6.5 PMI
Description
Drug development is an incredibly complex and risky endeavor, one that even experienced organizations will fail at more often than they succeed. This program will help you 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. At the end of the program, 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. These six modules will take approximately 6.5 hours to complete.
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. These six modules will take approximately 6.5 hours to complete.
- Module 1: Introduction to Drug Development;
- Module 2: Discovery and Pre-Clinical Phases;
- Module 3: Drug Development Phase 1;
- Module 4: Drug Development Phase 2;
- Module 5: Drug Development Phase 3 and Regulatory Review;
- Module 6: Drug Development Phase 4 and Lifecycle Management
- An Expensive and Risky Proposition;
- Regulations;
- Functional Areas;
- Workstreams; Timeline;
- Objectives and Key Players ;
- The IND and CTA; Phase 1 Studies ;
- Phase 1 Decisions;
- Regulatory Activities;
- Clinical R&D and Biostatistics Activities;
- End of Phase 2; Phase 3 Activities;
- Safety Reporting Requirements;
- Regulatory Review;
- The Common Technical Document;
- Objectives of Phase 4 and Lifecycle Management;
- The Product Lifecycle;
- Post-Approval Activities and Decisions;
- Lifecycle Management;
- Case Studies;
- Reviews;