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A PRIM&R Workshop

Exploring FDA Regulations

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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, will equip you with the skills necessary to navigate the complex landscape of FDA human subjects research regulations effectively. This workshop address a range of critical aspects of FDA regulations, from legal frameworks and compliance protocols to specific challenges associated with emerging technologies. Offered in three 2-hour sessions, through pre-learning modules and interactive exercises you will gain proficiency in applying the FDA regulations.

Cost:

Members: $350Nonmembers: $595

Agenda

Session 1:Introduction to the FDAExplore 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.
Session 2:Introduction to FDA's Oversight of Drugs and BiologicsLearn 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.
Session 3:Introduction to FDA's Oversight of Medical DevicesLearn about the classification, investigation of (IDE), marketing approval of medical devices. Understand the roles and responsibilities of sponsors and investigators.

You Will Learn To:

  • Analyze the intricate relationship between FDA regulations and ethical considerations in research involving drugs, biologics, and medical devices, proposing solutions for compliance and ethical integrity.
  • Evaluate FDA regulations in various research scenarios, making informed decisions to ensure compliance and address ethical dilemmas within the context of drugs, biologics, and medical devices.
  • Construct strategies for implementing FDA regulations, integrating legal, ethical, and practical aspects to promote compliance and participant welfare across the spectrum of drugs, biologics, and medical devices.

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.

Contributors

Kindra Cooper, JD, MPA, MA, CIP

IRB Director at Creighton University in Omaha, Nebraska, and an Unaffiliated Board Member with Advarra
Kindra Cooper is the IRB Director at Creighton University in Omaha, Nebraska, and an Unaffiliated Board Member with Advarra. She is responsible for oversight of Creighton University’s Human Research Protection Program and two institutional review boards (Biomedical and Social/Behavioral). Kindra is a regulatory and life sciences attorney. She earned her JD at the University of Washington School of Law. She also holds a Master of Bioethics and Health Policy from Loyola University Chicago, and a Master of Public Administration from The George Washington University. Prior to her role at Creighton, Kindra served as an IRB Chairperson for Advarra and in-house Regulatory Counsel for Quorum IRB. She is a published author on topics including eConsent and mobile medical applications. She has presented at national conferences and via online webinars on topics including IRB Myths, eConsent, and IRB review of medical device research.

Josh Fedewa

Director IRBMED, University of Michigan
Joshua has worked for more than 10 years in research specializing in human research participant protections. He has worked as a Clinical Research Educator, served as the Director of the IRB at the University of Texas Southwestern University, and most recently is serving as the Director of the IRBMED Office at the University of Michigan. He's managed many projects including:
  • Implementing a new electronic submission system;
  • Completing a full rewrite of an IRB Policy and Procedure Manual; and
  • Developing a quality review program.
Josh currently serves as an AAHRPP Site Visitor and has been through multiple intiial accreditations at institutions.
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