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

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

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10/9/2023 - 11/26/2023

$645

Online

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• SECTION ID:

  174910

• 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.

• 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 registered nurse.

• TEXTBOOKS:

  REQUIRED

  Pharmaceutical Regulatory Affairs: An Introduction for Life Scientists 1st
  by Dr. CF Harrison
  ISBN / ASIN: 9781537090740

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

  You may purchase textbooks via the UC San Diego Bookstore.

• POLICIES:

• NOTE:

  ***STUDENTS MAY ENROLL ANYTIME IN QUARTER, until November 1, 2023. Students must complete course by November 26, 2023, regardless of date of enrollment*** Refund deadline: one week after enrollment or start date of section, whichever is later.

• DATE & LOCATION:

  10/9/2023 - 11/26/2023
  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.