Bringing a new pharmaceutical product from the laboratory to the pharmacy requires years of bench research, and nonclinical research to assess the safety profile of the new drug. The next phase is careful clinical research on human subjects to assess the safety and efficacy of your product, constant interactions with FDA, manufacturing your product in the most efficient manner compliant with the appropriate regulations, and finally assembling a high-quality application that will be accepted and approved by the FDA.
Each of these steps requires a clear focus and is time and labor intensive. Your handling of the process can potentially accelerate, delay, or derail the approval process.
Good project management and excellent communications with FDA will enable your company to ensure timelines are met. The development plans that you craft will be your roadmap to ensuring you stay on course, or seek alternate routes whenever speedbumps present themselves. This course will enable you to have an appreciation/understanding of the critical processes associated with drug development
This course will cover the following areas of new drug development and associated challenges…
- Preclinical research
- Preparing for the Pre-IND
- Opening an IND
- Clinical Research (Phase 1, 2 and 3)
- Development Plans
- Pediatric studies
- Posting your clinical trials to Clinicaltrials.gov
- Interactions with FDA to discuss your drug development
- Assembling the New Drug Application
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