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.

REQUIRED TEXTBOOKS:
Pharmaceutical Regulatory Affairs: An Introduction for Life Scientists , 1st Edition
Author: Dr. CF HarrisonISBN / ASIN: 9781537090740

FDA Regulatory Affairs , 3rd Edition
Author: Mantus/ PisanoISBN / ASIN: 9781841849195
 

Course Number: FPM-40189
Credit: 3.00 unit(s)
Related Certificate Programs: Clinical Trials Design and Management

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4/8/2024 - 5/24/2024

$645

Online

Closed

• SECTION ID:

  179629

• 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:
  

  Morton, James

  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.  

• TEXTBOOKS:

  No textbook required.

• POLICIES:

• NOTE:

  ***STUDENTS MAY ENROLL ANYTIME IN QUARTER, until May 1, 2024. Students must complete course by May 24, 2024, re gardless of date of enrollment***Refund deadline: One w eek after enrollment.

• DATE & LOCATION:

  4/8/2024 - 5/24/2024
  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.

7/15/2024 - 8/30/2024

$645

Online

Add To Cart

• SECTION ID:

  182125

• 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:
  

  Morton, James

  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.  

• TEXTBOOKS:

  No textbook required.

• POLICIES:

• NOTE:

  ***STUDENTS MAY ENROLL ANYTIME IN QUARTER, until August 7,2024. Students must complete course by August 30, 20 24, regardless of date of enrollment.***Refund deadline : one week after enrollment or start date of section, w hichever is later..

• DATE & LOCATION:

  7/15/2024 - 8/30/2024
  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.