This course reviews the breadth of U.S. and international regulations associated with the development of drugs, biologics, medical devices, and diagnostics. Topics include a review of regulatory agencies and the role/responsibilities of each; pathways for regulatory applications; important differences between development processes in the U.S. and those of other countries; and the impact of regulatory approval processes on corporate strategy.
Other Credits: BRN: 24 CE hours.
Note: Elective for Professional Certificate in Clinical Trials Design and Management.
Course Number: FPM-40189
Credit: 3.00 unit(s)
Related Certificate Programs: Clinical Trials Design and Management
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4/10/2023 - 5/26/2023
This course is entirely web-based and to be completed asynchronously between the published course start and end dates. Synchronous attendance is NOT required.
You will have access to your online course on the published start date OR 1 business day after your enrollment is confirmed if you enroll on or after the published start date.
Olson, Suzan, Formative/Summative Usability/Human Factors Testing in Medical Device and Combination Products
Suzan Olson works with manufacturers to plan and execute human factors evaluations and clinical trials covering pediatrics and adults of combinations products and medical devices. She earned a doctorate in psychology and a master's in health administration from Wichita State University as well as a bachelor's in health administration from Ottowa University. She is also a registered nurse.
No information available at this time.
***No Textbook Required***
Refund deadline: one week after enrollment or start date of section, whichever is later.
4/10/2023 - 5/26/2023
You will have access to your course materials on the published start date OR 1 business day after your enrollment is confirmed if you enroll on or after the published start date.
There are no sections of this course currently scheduled. Please contact the Healthcare & Behavioral Sciences department at 858-534-9262 or email@example.com for information about when this course will be offered again.