login

A PRIM&R Advanced Core Training

Navigating the Nuances of FDA-Regulated Research

Tuesdays, October 14 and 21 | Thursday, October 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
Dates are subject to change.
Purchase

Agenda

Tuesday, October 14 1:00–3:00 PM ET
Tuesday, October 21 1:00–3:00 PM ET
Thursday, 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 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?

  • 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
Mr. Garimella is the Director of the Human Research Protection Program (HRPP) at Indiana University, overseeing human participant research across all IU campuses (Bloomington, Indianapolis, and other regional campuses) and affiliated hospitals throughout Indiana. He is primarily responsible for the strategic direction and functions of the IU HRPP, which includes the Human Subjects Office (HSO) and the Quality Improvement Office (QIO). Previously, he spent over a decade at the University of Michigan Medical School’s IRBMED, where he led multiple regulatory teams and managed 15,000+ submissions annually. With over 15 years of experience in research compliance, Mr. Garimella specializes in FDA-regulated research, IRB operations, and advancing regulatory practices. He has developed educational programs for IRB professionals and regularly presents on emerging regulatory challenges. Mr. Garimella holds a Master of Science in Clinical Research Administration and a Bachelor of Pharmacy in Pharmaceutical Sciences. Additionally, he obtained and maintains professional certifications: Certified IRB Professional (CIP) from PRIM&R and Regulatory Affairs Certification (RAC) from RAPS.

Erin M. Odor, MA, CIP

Full-time IRB chairperson at Advarra
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.