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Joint Fellowship Training Program
Program 3
Oncology Product Research/Review Fellows
Training Goals and Outcomes
- Understanding of cancer biology relevant to molecular targeted therapy.
- Understanding of regulatory requirements for product development and approval process and participation in the review of regulatory files (e.g. IND, NDA, BLA, 510k, PMA) for chemistry, manufacturing control, pharmacology/toxicology and clinical trial design.
- Participation in the development of product standards and guidance document development.
- Understanding of critical ethical issues and requirements in product research, development, and review, including protection of human research subjects and conflict of interest.
- Understanding the manufacturing processes, e.g., production, purification, characterization, testing, quality control, and quality assurance.
- Participation in and understanding of product-related research, i.e. understanding the biology, chemistry, pharmacoepidemiology, manufacturing, post-marketing surveillance, and mechanism of action/pathogenesis.
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