CT: Drug Development Process
FPM-40173
This keystone course examines the drug development process and history of clinical trials. Topics include sources of new drugs & devices; the process of discovery; how a discovery becomes a drug or device; the definition, phases, and purposes of both pharmacological and clinical development; the history of drug/device regulation and effects of historical events on regulatory oversight; investigative new drug applications; and premarket approval applications.
Course Information
Course sessions
Section ID:
Class type:
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:
Schedule:
Instructor:
Suzan Olson, PhD, MHS, RN
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.
Section ID:
Class type:
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:
- No refunds after: 9/30/2025
Schedule:
Instructor:
Georgie Cusack
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.
