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, Medical Writing
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7/1/2019 - 8/23/2019