A PRIM&R Workshop
FDA Regulations
March 10, 17, and 24, 2026
1:00–3:00 PM ET Learning Lab: March 20 | 1:00–2:00 PM ET
Overview
Effective oversight of FDA-regulated research is essential to protecting human subjects, ensuring regulatory compliance, and maintaining public trust in the research enterprise. Professionals responsible for the review and oversight of studies involving FDA-regulated drugs, biologics, and medical devices must navigate a complex and evolving regulatory environment shaped by federal requirements, agency guidance, and scientific innovation. This workshop is designed as a comprehensive educational resource for individuals engaged in the ethical and regulatory oversight of FDA-regulated research involving human subjects.
The workshop is tailored for professionals working within IRBs, HRPPs, research compliance offices, academic medical centers, contract research organizations, and industry settings who require a practical, applied understanding of FDA regulations. Through a multifaceted instructional model—including pre-learning modules, interactive exercises, and real-world case studies—participants will strengthen their ability to interpret and apply FDA regulatory requirements in research settings.
The curriculum addresses core components of FDA oversight, including legal authority, regulatory scope, sponsor and investigator responsibilities, and compliance expectations related to investigational drugs and devices. Participants will also examine common oversight challenges, such as distinguishing FDA-regulated research from nonregulated activities, managing complex study designs, and responding to deviations and noncompliance.
Recognizing the rapid evolution of research methods, the workshop explores regulatory considerations related to emerging technologies and novel research approaches, including decentralized trials and digital health tools. By the conclusion of the program, participants will be better equipped to support compliant, ethically sound FDA-regulated research and to apply regulatory requirements consistently within their institutional or organizational context.
Cost:
Members: $330Nonmembers: $565
Join PRIM&R today to save $235 on this workshop, plus free registration to all webinars, and more exclusive benefits.
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You will learn how to:
Analyze the intricate relationship between FDA regulations and ethical considerations in research involving drugs, biologics, and medical devices, proposing solutions for compliance and ethical integrity.
Evaluate FDA regulations in various research scenarios, making informed decisions to ensure compliance and address ethical dilemmas within the context of drugs, biologics, and medical devices.
Construct strategies for implementing FDA regulations, integrating legal, ethical, and practical aspects to promote compliance and participant welfare across the spectrum of drugs, biologics, and medical devices.
CE Credit
Participants will receive a certificate of attendance that documents up to 7 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.
Presenters
Kindra Cooper, JD, MPA, MA, CIP
Josh Fedewa, MA CIP
CIP® Credit
Participants holding the Certified IRB Professional (CIP®️) credential may apply 7 continuing education credits towards CIP recertification. Please refer to the CIP®️ recertification guidelines for additional information.
Access Interval
Access to live content will be available for 90 days after the recording is made available. After 90 days, access to the content will be removed, but users will retain access to any certificates of attendance earned. To earn a certificate, one must complete all required sections and complete the certificate section within the 90-day access period. After access has expired, users can purchase an additional 90 days of access.
Accommodation Statement
PRIM&R is committed to hosting inclusive, accessible events that enable all individuals to engage and participate fully. For inquiries about session accessibility or requests for specific accommodations, please contact Onlinelearning@primr.org. Requests for American Sign Language interpreters and/or CART providers should be made at least two weeks in advance of the event. Please note that PRIM&R will make every effort to secure services, but that these services are subject to availability.