NCPHACS008 — Regulatory Affairs Regulations
Cost: $1200.00. **Prerequisite: Foundations of Clinical Development.** Required: Access to a computer, Microsoft Office compatible software, a web browser (either Mozilla Firefox or Google Chrome) and reliable access to the Internet. Introduces you to the impact of regulation on clinical development of new biologics, pharmaceuticals, and vaccines. Upon completion of this course, you will be able to describe the differences between an Investigational New Drug Application (INDA), a Biologic License Application (BLA), a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), and a PreMarket Application (PMA). You will also gain an understanding of FDA and ICH guidelines and regulations as well as the FDA Bioresearch Monitoring program.