A PRIM&R Core Training
FDA-Regulated Research
Tuesdays | September 25, October 1 & 8
1:00–3:00 PM ET
Learning Labs Thursdays | October 3 & 10
Overview
This introductory 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.
Agenda
Tuesday, September 25
1:00–3:00 PM ET
Tuesday, October 1
1:00–3:00 PM ET
Tuesday, October 8
1:00–3:00 PM ET
Learning Labs
Thursdays | October 3 & 10
1:00–2:00 PM ET
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.
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
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. Josh currently serves as an AAHRPP Site Visitor and has been through multiple intiial accreditations at institutions.