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A PRIM&R Workshop

Navigating the Nuances of FDA-Regulated Research

Tuesdays | October 14, 21, & 30, 2025 1:00–3:00 PM ET

Learning Labs | Thursdays | October 16 & 23
Register Here

Overview

This advanced-level, three-session workshop is designed for research compliance professionals, regulatory affairs professionals, clinical research coordinators, and others involved in the study, oversight, and regulation of drugs, biologics, and devices. Through interactive exercises, immersive case studies, and expert-led presentations, you will gain proficiency applying the FDA regulatory framework to advanced scenarios. Explore real-life examples of research with FDA-regulated products and test articles, including emerging technologies; use existing resources to support regulatory determinations; and consider ongoing oversight with an emphasis on protecting human subjects. A prerequisite for this workshop is a foundational knowledge of FDA research regulations governing human subjects protection and the conduct of clinical trials. You should be familiar with common definitions; history and organization of the FDA; criteria for exemption from IND and IDE requirements; and sponsor, investigator, and IRB responsibilities in the conduct and oversight of FDA-regulated clinical trials. This workshop, "Navigating the Nuances of FDA-Regulated Research" provides opportunities for you to apply inductive reasoning and resourcefulness to real-world scenarios you may encounter in the future.

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?

  • Identify and use resources to interpret and apply FDA-regulations to unique products or study design scenarios.
  • Employ analytical frameworks to chart a course for compliance with FDA research regulation.
  • Formulate requisite determinations, document rationales, and obtain useful agency input where needed.

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.