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)

BIRS Learning Community

Brought to you by:

BIRS Learning Community

Reviews

We couldn't find any reviews for this course. How would you like to be the first?

  1. Enroll in the course.
  2. Get your learn on!
  3. Come back and tell us about the experience.

How do I enroll?

Find the description page for the course you want to take (hint: you're on one right now). Look for an "enroll" button and click it. If you don't see the button, the course currently isn't active.

Can I review without enrolling?

Sorry, no. To review a course you must have taken the course.