Courses
Advanced Topics in Documents and Dialogues
Documents and Dialogues of Drug Development and Registration: This capstone advanced course will integrate previous learning relating to laws and regulations, quality principles and practices, and the preparation and submission of documents for preclinical research clinical trials and new drug approvals. Special topic lectures will be given. Considerable time will be devoted to preparing regulatory documents and conducting "mock" dialogues and negotiations with "pretend" agency officials. (3 credits)
The Advanced Topics in Documents and Dialogues course will build upon the core concepts from Documents and Dialogues, integrating learning relating to laws and regulations, quality principles and practices, and the preparation and submission of documents for new and generic drug approvals. Special topic lectures will be given. Time will be devoted to preparing regulatory documents and conducting “mock” dialogues and negotiations with “pretend” agency officials. Dialogues related to regulatory and quality issues will also be addressed.