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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

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Section ID:

191526

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:

FDA Regulatory Affairs 3rd
by Mantus/ Pisano
ISBN / ASIN: 9781841849195

You may purchase textbooks via the UC San Diego Bookstore.

Policies:

Note:

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

Schedule:

No information available at this time.
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Instructor: Georgie Cusack

Georgie Cusack
Georgie Cusack received her bachelor's and master's degrees from the University of Maryland School of Nursing.  She worked in clinical trials for 33 years at the National Institutes of Health in a variety of capacities, including Clinical Research Nurse and Clinical Nurse Specialist in Hematology-Oncology, Breast Cancer Research Nurse Specialist, Director of Research Nursing for the National Heart, Lung, and Blood Institute (NHLBI), and Director of Education and Outcomes for NHLBI. She has served as a principal and Associate Investigator on several studies, primarily in oncology/hematology.
Mrs. Cusack has trained healthcare professionals locally, nationally, and internationally in oncology and clinical trials for over 25 years.  She has traveled to 15 countries to share her expertise in clinical trials and oncology. Mrs. Cusack was part of a presidential initiative team that helped develop a premier cancer center in Amman, Jordan.  She also assisted in developing a tool to measure protocol workload and designed clinical trials courses for healthcare professionals.   She has published in several peer-reviewed journals on topics related to clinical trials, genetics, genomics, and oncology. She is board-certified as an Advanced Oncology Clinical Nurse Specialist by the Oncology Nursing Certification Corporation and as a Nurse Coach by the American Holistic Nursing Certification Corporation.
 
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