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A PRIM&R Core Training

FDA-Regulated Research

Thursday, September 25, 2025 | Wednesdays, October 1 and 8, 2025

1:00–3:00 PM ET

Learning Labs Fridays, October 3 and 10, 2025
Register Here

Overview

This workshop is an essential resource for professionals involved in the conduct, review, or oversight of FDA-regulated research on drugs, biologics, and medical devices. Designed to build foundational knowledge, the program is ideal for individuals working at academic medical centers, research hospitals, contract research organizations, pharmaceutical or biotechnology companies, and federal agencies—as well as those serving on or supporting institutional review boards (IRBs), quality assurance units, or regulatory affairs offices. Whether you're a clinical research coordinator, IRB administrator, regulatory specialist, investigator, research compliance officer, or part of a research ethics or legal team, this workshop offers the tools and context needed to navigate FDA human subjects research regulations with confidence. Through a dynamic educational experience that blends pre-learning modules, live instruction, interactive exercises, and real-world case studies, participants will gain practical, applicable knowledge of the FDA’s regulatory framework. The course explores core legal and compliance requirements while examining the nuanced challenges that arise in today’s research landscape, including those related to emerging technologies, decentralized trials, and multisite studies. Over three 2-hour sessions, attendees will learn to interpret and apply the FDA regulations in day-to-day research oversight and decision-making. The curriculum provides clarity on how FDA requirements differ from or align with HHS regulations, and how those differences affect institutional practices and participant protections. By the end of the program, participants will leave with greater proficiency in applying regulatory concepts to their roles, enhanced confidence in supporting compliant and ethical research, and a stronger ability to contribute meaningfully to their organization’s mission of protecting human subjects in research.

Cost:

Members: $350Nonmembers: $595
Dates are subject to change.
Purchase

Agenda

Thursday, September 25 1:00–3:00 PM ET
Wednesday, October 1 1:00–3:00 PM ET
Wednesday, October 8 1:00–3:00 PM ET
Learning Labs Fridays | October 3 & 10 1:00–2:00 PM ET

CE Credit

Participants will receive a certificate of attendance that documents up to 8 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. Participants holding the Certified IRB Professional (CIP®) credential may apply 8 continuing education credits towards CIP recertification. Please refer to the CIP® recertification guidelines for additional information.

What Will I Learn?

  • Understand the foundational FDA regulations that govern human subjects research involving drugs, biologics, and medical devices.
  • Distinguish between FDA and HHS regulatory requirements and apply them appropriately in research oversight.
  • Navigate the compliance challenges associated with emerging technologies and decentralized or multisite trials.

Presenters

Kindra Cooper, JD, MPA, MA, CIP

Director of IRBMED, University of Michigan
Kindra Cooper is a regulatory and life sciences attorney currently serving as the Director of IRBMED for the University of Michigan. She is also proud to serve as Regulatory Faculty for the Radiological Society of North America's Annual Clinical Trials Workshop. Prior to her appointment at Michigan, Kindra was an Assistant Clinical Professor in the Department of Medical Humanities at Creighton University where she also served as IRB Director. Kindra has also previously served as an IRB Chairperson for Advarra and as Senior Regulatory Counsel for Quorum Review IRB. 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, MS, CIP

Director of Research Compliance, Advarra
Joshua Fedewa is an expert in human subject research. He has over fifteen years of experience in regulations and guidelines governing human subjects research. Josh is currently the Director of Research Compliance at Advarra. Previously the director of IRBMED at the University of Michigan and Director of the IRB at the University of Texas Southwestern Medical Center, Joshua held direct responsibility for over 20,000 submissions as well as 5,500 active studies. Joshua’s experience also includes oversight over all IRB operations at academic medical centers. He has expertise in human subjects regulations oversight and operations (IRB), as well as HIPAA Privacy regulations, and research compliance investigations. He has been instrumental in managing animal care and biosafety oversight at an academic medical center affiliate. Josh has extensive experience with a variety of electronic IRB submission and review systems and is also skilled in helping institutions obtain and maintain initial AAHRPP accreditation.