Course Information

Section Id	: GMS CI 640 OL
Name	: Regulatory and Compliance Issues
Program	: Finance
Program Detail	: Prereq: Premedical course requirements and consent of instructor. Course explains the regulatory requirements for healthcare products, that is, drugs, biologics, diagnostics, and devices. Intended for those interested in regulatory affairs or in the clinical evaluation, development, manufacture, testing and/or commercialization of these products. An in-depth review will be provided of the pertinent FDA regulations and guidelines and links these to the scientific and logistical activities involved in taking a product from research to market. Content and preparation of regulatory submissions, including an Investigation New Drug Application (IND), an Investigational Device Exemption (IDE), a New Drug Application (NDA), a Biologic License Application (BLA), a Pre-Market Approval Application (PMA), and a 510K PreMarket Notification are described. International requirements for health care products are also reviewed.
Prerequisite	:
Course Level	: Online Undergraduate Courses
Course URL	: http://www.bu.ed...vestigation.html
Additional Information
- Search for threads in the forum related to this online course

College and University Contacts and Details

Name		: Boston University
Online Distance Education Page		: http://www.bu.edu/
College/University Main Page		: http://www.bu.edu/
Street Address		: 121 Bay State Road
City	: Boston	State	: Massachusetts
Zip	: 02215	Country	: United States of America
Email	: admissions@bu.edu
Phone	: 617-353-2300	Fax	: 000-000-0000
AACSB

Short Profile

Additional Information

- List online courses offered at this institution

- Check reviews given by other users; you can also add your own review or a comment

- Search for threads in the forum related to this institution