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Course

CT: Regulation of Drugs, Biologics, Devices, and Diagnostics

FPM-40189

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.

Course Information

Online
3.00 units
$645.00
Notes: Elective for Professional Certificate in Clinical Trials Design and Management.

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This course applies to these programs

Clinical Trials Design and Management

Course sessions

Closed

Section ID:

185926

Class type:

Online Asynchronous.

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.

Textbooks:

No textbook required.

Policies:

Note:

Refund deadline: one week after enrollment or start date of section, whichever is later.

Schedule:

No information available at this time.
Closed

Instructor: James Morton

James Morton
Dr. James Morton received his doctorate of pharmacy degree form the University of Southern California. He is a Senior clinical research professional with over a decade of experience in clinical operations as a consultant, with AbbVie and Therapeutics Incorporated and over a decade of experience in clinical development with Quest Diagnostics. He has developed specific expertise in planning, implementation, oversight, monitoring, project management and completion of clinical studies. His work as lead to successful FDA approvals for three BOTOX indications; glabella lines, hyperhidrosis and migraine headache. Additionally he has supported successful clinical validations of over 50 LDT, including EUA for Quest COVID-19 At-Home Rapid Antigen Test.
 
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