Exploring FDA Regulations  Workshop One

Wednesdays, April 3, April 10, and April 17, 2024
1:00-3:00 PM ET

Overview

Overview

This introductory workshop is an essential resource for professionals engaged in the study or oversight of FDA-regulated drugs, biologics, and medical devices.

By employing a multifaceted educational approach that includes pre-learning modules, hands-on exercises, and real-world case studies, you will be equiped with the skills necessary to navigate the complex landscape of FDA human subjects research regulations effectively. 

Offered in three 2-hour sessions, through pre-learning modules and interactive exercises you will gain proficiency in applying the FDA regulations.  

Agenda

Session 1:
Introduction to the FDA
Explore the history, mission, structure of the FDA. Learn about the scope of Human Subjects Research Protections in FDA regulated research and the responsibilities of IRB's.
Wednesday, April 3, 2024
1:00-3:00 PM ET

Session 2:
Introduction to FDA's Oversight of Drugs and Biologics
Learn about the FDA marketing approval of drugs, and biological products.Understand the clinical investigation of a drug, biological product and the responsibilities of sponsors, investigators.
Wednesday, April 10, 2024
1:00-3:00 PM ET

Session 3:
Introduction to FDA's Oversight of Medical Devices
Learn about the classification, investigation of (IDE), marketing approval of medical devices. Understand the roles and responsibilities of sponsors and investigators. 
Wednesday, April 17, 2024
1:00-3:00 PM ET

Intersession​ Learning Labs
Fridays, April 
1:00–2:00 PM ET

What Will I Learn?

What Will I Learn?

  • Learn to address a range of critical aspects, from legal frameworks and compliance protocols to specific challenges associated with emerging technologies.
     
  • Become proficient in applying the FDA regulatory framework to a variety of real-life scenarios involving clinical trials of drugs, biologics, and medical devices in human subjects.

Contributor

Kindra Cooper, JD, MPA, MA, CIP

Kindra Cooper, JD, MPA, MA, CIP

IRB Director at Creighton University in Omaha, Nebraska, and an Unaffiliated Board Member with Advarra

David Babaian, JD, LLM, CIP, RAC

David Babaian, JD, LLM, CIP, RAC

General attorney for the U.S. Department of Veterans Affairs

CE Credit

Participants will receive a certificate of attendance that documents up to 6 continuing education credit hours for their attendance at this workshop. Certificates of attendance are useful for obtaining CE credits from professional associations. Each association's guidelines for accepting CE credit hours (in-person or virtual) may differ. Please consult the appropriate association representative for information on if, and how many, CE credits from this PRIM&R workshop may be used.

Cost

Cost

Members: $350

Nonmembers: $595