Monday, May 25, 2009

Clinical Trials Reports

I thought I was going to have this ready by now, but with my move out of Texas and all the work with a book we are working on, the Clinical Trials Reports course had to wait. 

We seem to be back on track with this and, if all goes well, we'll be releasing this course at next month. Just to give you a preview, these are some of the topics included in the online course:
  • Pre-submission Quality Control
  • Pre-IND, Pre-IDE
  • IND, IDE
  • Investigator Brochure
  • NDA, PMA
  • Panel Pack
  • Post-approval Reports
  • Recurring Regulatory Reports
  • Manuscripts & Abstracts
If you are not familiar with regulatory writing, you may want to look first at Introduction to Regulatory Writing in the US. The upcoming course is a great follow-up to that one, and it will show you how to write all these important reports. 

Sign up for email updates to this blog (see right-hand column) to be notified when the course is released.

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