Topics
- The purpose of Pre-clinical studies
- The transition from discovery to development
- Milestones on The "Dual Path" to Drug Commercialization
- The four major clinical phases (1-4) in the drug development process and the rationale for each with key deliverables
- Overview of the key government regulations that impact the development process (Code of Federal Regulations and ICH)
- Where do IND and NDA fit into the process
- The criticality of effective project management for cross-functional teams during the development process with special focus on managing activities performed by contract manufactures, labs and suppliers
- Designing the drug with the patient and regulations in mind
The Drug Development Process - From R&D to Commercialization brings together Clinical monitors and research associates, Research & development scientists, Statisticians & data management professionals, Medical and clinical investigators and study coordinators, Regulatory Affairs Professionals, CMC/pharmaceutical research professionals, Senior sales managers, Project Managers, Program Management and Analytical Development.
