DESCRIPTION
This course provides an overview of FDA regulation and policy covering the identification, jurisdiction and review of combination products.
LEARNING OBJECTIVES
Upon completion, participants will:
- Recognize the differences among drugs, devices, biologics, and combination products
- Define primary mode of action
- Understand the special procedures for determining jurisdiction and review assignment of combination products
- Understand the elements of a Request for Designation submission
TARGET AUDIENCE
This program is designed for new regulatory affairs professionals and others in related departments interested in understanding the basics of the regulation of combination products.
Cost: Member $150; Nonmember $225
Type: Web-based Class
RAC Points: Participants receive 2 RAC points.
Frequently Asked Questions
What is the time period of the course and when is the end date?
You will have 60 days to complete the course from the time of your purchase. The end date is calculated from your purchase date. You can complete the course work at any time, day or night, that fits into your schedule. There is no pre-assigned time that you need to be online. It is a completely self-paced online course.
How many hours will it take to take the course?
It will take approximately 2 hours online to complete the course. This includes time for the final exam.
Is there any home work?
No, all the information you need to complete the course is included in the online course materials.
Is there any special computer requirements for access or software that must be downloaded?
RAPS Online University works best with an up-to-date version of IE explorer or Firefox. A current version of Flash is a common plug-in used in our courses. For your convenience, the URL to download this plug-in can be found at www.macromedia.com.
Is the purchase of any additional text required?
No, all the information needed to complete the course is included in the online course. However, RAPS does offer books on Ethics that you may find of interest as supplemental reading to the course, but they are not required texts and you may complete the course without them.