TLI 52400

The Documents And Dialogues Of Drug Delivery 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.

Credit Hours: 




West Lafayette