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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.