Log In
Contact Us
  • About Us
    • Who We Are
    • PRIM&R Partners
    • Resources
    • Ampersand Blog
    • Career Center
  • Conference
    • Annual Conference
    • Exhibit
    • Past Conferences
  • Certification
    • Eligibility
    • Certification Exams
    • CIP and CPIA Councils
    • CIP and CPIA Recertification
  • Programs
    • Education at PRIM&R
    • AI Education Bundle
    • Flash Learn
    • Workshops
    • Seminars
    • Symposium
    • Courses
    • Webinars
    • Certificates
  • Membership
    • Member Benefits
    • Member Hub
  • Understanding Research
    • Research Ethics Timeline
    • Lead the Way
    • Research Ethics Reimagined Podcast
    • People and Perspectives
  • Public Policy
    • Research Ethics in Public Policy
    • Advocacy Toolkit
    • Resources
    • Federal Public Policy Briefings
    • Policy Comments
  • Support Us
    • Donate
    • Volunteer
    • Sponsor
    • Bookstore
  • Policies
    • PRIM&R Policy
    • Events Code of Conduct
    • Reporting Misconduct
  • Blog

A PRIM&R Workshop

Navigating the Nuances of FDA-Regulated Research

Purchase Recording

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

What Will I Learn?

After attending the workshop, attendees will be able to:
  • 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 regulations.
  • Formulate requisite determinations, document rationales, and obtain useful agency input where needed.

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.

Contributors

Belinda Smith, MS, RD, CCRC

Research Education Specialist for the University of Kentucky (UK) Office of Research Integrity
Responsible for the provision of education programs to all constituents of the Human Research Protection Program (HRPP), consultation and review of FDA-regulated clinical research and HRPP accreditation maintenance. In 2020, the UK Education Program was recognized as an Area of Distinction by AAHRPP. Belinda was instrumental in creating the UK Informed Consent Workshop, From Perception to Process, which received the 2018 Human Research Protect Award of Excellence for Best Practice. Additionally, she has contributed curricula to the Collaborative Institutional Training Initiative (CITI) and is a contributing author to the third edition of IRB Management and Function by Bankert, Gordon, Hurley, and Shriver (Eds). As a Certified Clinical Research Coordinator for the UK Metabolic Research Group (MRG), she managed NIH, VA, and Industry funded trials in the areas of lipid disorders, diabetes, nutrition, and obesity. She served as the Regulatory and Education Coordinator for the UK Clinical Research Organization from 2000 through 2008. She has co-authored publications and presented at national conferences in the areas of metabolic research, clinical research, and human research protection.

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.
Contact UsLogin
About Us
Who We Are
PRIM&R Partners
Career Center
Space
Conference
Annual Conference
Past Conferences
Space
space
Certification
Eligibility
Certification Exams
Recertification
Certification Councils
PRIM&R Membership
PRIM&R Member Benefits
Member Hub
Space
Donate
Volunteer
Sponsor
Space
Space
Terms and Conditions
Privacy Policy
PRIM&R Policy
Cookie Policy
Copyright © 2025 PRIM&R. All rights reserved.

We use cookies to enable essential functionality on our website, and analyze website traffic. By clicking Accept you consent to our use of cookies. Read about how we use cookies.

Your Cookie Settings

We use cookies to enable essential functionality on our website, and analyze website traffic. Read about how we use cookies.

Cookie Categories
Essential

These cookies are strictly necessary to provide you with services available through our websites. You cannot refuse these cookies without impacting how our websites function. You can block or delete them by changing your browser settings, as described under the heading "Managing cookies" in the Privacy and Cookies Policy.

Analytics

These cookies collect information that is used in aggregate form to help us understand how our websites are being used or how effective our marketing campaigns are.