CT: Drug Development Process

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.

Other Credits: BRN: 24 CE hours (Provider number: CEP 58)

Note: Requirement for Professional Certificate in Clinical Trials Design and Management - this is the first course in that certificate. Prerequisite for Science of Clinical Trials Design, Good Clinical Practices, and Human Subjects Protection & IRBs.

Course Number: FPM-40173
Credit: 3.00 unit(s)
Related Certificate Programs: Clinical Trials Design and Management, Medical Writing

+ Expand All

1/4/2021 - 2/22/2021

$545

Online

Add To Cart

• SECTION ID:

  152250

• CLASS TYPE:

  Online Asynchronous.
  
  All instruction and course materials delivered and completed online between the published course start and end dates.

• INSTRUCTOR:
  

  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 registerd nurse.

• TEXTBOOKS:

  REQUIRED

  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.

• DATE & LOCATION:

  1/4/2021 - 2/22/2021
  extensioncanvas.ucsd.edu
  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.