DESCRIPTION
This course provides a basic understanding of regulatory planning for medical devices and the relationship between regulatory strategy, product development and business outcome. The course covers a wide range of issues including how medical devices are defined and regulated, how medical device companies assess registration requirements in these countries, sources of competitive intelligence, factors to consider in selection of a particular pathway, and the consequences for failing to consider different entry options into these constituencies.
LEARNING OBJECTIVES
Upon completion, participants will:
- Describe the elements impacting on medical device definition and classification globally
- Identify the questions to consider in development of regulatory strategy
- Define the tools for regulatory planning
- Identify strategic regulatory professional characteristics
- Identify sources of regulatory intelligence
- Identify the elements of a regulatory plan
- Identify the benefits of a well developed and executed plan
TARGET AUDIENCE
This course is intended to provide regulatory affairs professionals with an introduction to some of the resources and tools used in the development of global regulatory strategy for medical devices as well as the characteristics and behaviors of strategic regulatory professionals. The program is designed for those who are interested in or may be involved in global regulatory strategy as it relates to medical devices and related products.
Cost: Member $200; Nonmember $275
Type: Web-based Class
RAC Points: Participants receive 3 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 3 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.