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A PRIM&R Workshop

FDA-Regulated Research

Tuesdays | September 2, 9, & 16, 2025

1:00–3:00 PM ET

Learning Labs Thursdays | September 4 & 11
Register Here

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.

Cost:

Members: $350Nonmembers: $595

Agenda

Tuesday, October 14 1:00–3:00 PM ET
Tuesday, October 21 1:00–3:00 PM ET
Tuesday, October 30 1:00–3:00 PM ET
Learning Labs Thursdays | October 16 & 23 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

Purna Garimella, MS, CIP, RAC

Director of the Human Research Protection Program (HRPP) at Indiana University,
Purna Garimella is the Director of the Human Research Protection Program (HRPP) at Indiana University, overseeing the ethical and regulatory conduct of human subjects research across all IU campuses and affiliated health systems. With more than 15 years of experience in clinical research and regulatory affairs, Mr. Garimella brings deep expertise in FDA-regulated research, IRB operations, and institutional compliance. Previously, Mr. Garimella spent over a decade at the University of Michigan Medical School’s IRBMED, where he advanced through several roles to become Assistant Director. In that role, he led multiple regulatory teams, oversaw more than 15,000 submissions annually, and implemented process improvements that significantly reduced IRB turnaround times. Mr. Garimella has developed training programs for IRB professionals and regularly presents on FDA-regulated research and emerging regulatory challenges. He holds a Master of Science in Clinical Research Administration and a Bachelor of Pharmacy in Pharmaceutical Sciences, along with professional certifications as a Certified IRB Professional (CIP) and in Regulatory Affairs Certification (RAC). He is also a PRIM&R Mentor, a member of AEREO (The Consortium to Advance Effective Research Ethics Oversight), a member of the Big Data IRB Collaborative Working Group on Artificial Intelligence (AI)/Machine Learning (ML), and a co-chair of the Human Subjects Research Committee for the PRIM&R annual conference.

Erin M. Odor, MA, CIP

Advarra as a full-time IRB chairperson
Joined Advarra as a full-time IRB chairperson in May 2022. In addition to chairing IRB meetings, she serves as a subject matter expert in FDA-regulated research with a focus on medical devices. Previously, Erin served as a quality improvement specialist for regulatory, education, and policy analysis at Ohio State University’s Office of Responsible Research Practices. In that role, she established an internal QI assessment program of IRB operations, managed the university’s IRB blog, and co-authored a university-wide policy governing the use of protected health information in research. She also served on the university’s conflict of interest advisory committee and privacy board.
Erin has extensive experience developing and delivering educational content for adult learners, including hands-on workshops, self-paced eLearning courses, and graduate-level course materials. A Certified IRB Professional, Erin has contributed articles to blogs such as Ampersand and serves on the PRIM&R Conference Poster Review Committee.
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