This new course was developed by a regulatory writer with more than 20 years of experience in the field, and it will show you how to develop:
- Pre Investigational New Drug (IND) Application
- Investigational New Drug (IND) Application
- Investigational New Drug (IND) Reports
- Informed Consent Form
- Investigator’s Brochure
- Clinical Reports
- Pre New Drug Application (Pre-NDA)
- New Drug Application (NDA)
- Patient Narratives
While the Introduction to Regulatory Writing course teaches the drug development and approval process in the US, the Clinical Reporting Course is a practical guide to prepare the regulatory documents involved in clinical research.
The course has been released at an introductory cost of $197, but will go up to $247 on July 6, 2009. Click here for more information.