FDA-Regulated Research

Webinar Bundle: FDA-Regulated Research

The FDA-Regulated Research webinar bundle is made up of a curated selection of PRIM&R's recorded webinars, hand-picked to provide in-depth instruction. Developed and presented by experts, the webinars in this bundle offer insight into some of the fundamental concepts and challenges involved in FDA regulations. Webinar topics include the difference between FDA and DHHS regulations, ethical considerations in expanded access, and reviews of studies involving in-vitro Diagnostics.

Continuing Education

 Webinar viewers holding the Certified IRB Professional (CIP®) credential may apply continuing education credits from each webinar towards CIP recertification. This webinar bundle is eligible for a total of 6 continuing education credits. Learn More »

Included Webinars

Expanded Access: Ethical and Regulatory Issues for Investigational Drugs and Devices

2010

Speakers: George Gasparis, CIP and Richard Klein

In this webinar, speakers provide an overview of the complex policies that govern expanded access programs involving both investigational drugs and devices.

Presented by expert faculty representing both the regulatory and institutional perspectives, this webinar:

  • Broadens attendees' understanding of expanded access programs and how they differ from clinical research
  • Explores the ethical and regulatory implications of expanded access programs for IRBs, patients, healthcare providers and researchers
  • Teaches views how to interpret and apply investigational drug and investigational device regulations regarding expanded access
  • Advances attendees' thinking about, and management of, these complex issues

Participation in this 90-minute webinar counts as 1.5 CE credit hours.

FDA Oversight and IRB Review of Studies that Include In-Vitro Diagnostics

2015

Speakers: Jonathan M. Green, MD and E. David Litwack, PhD

IVD products are medical devices or biological products intended to diagnose disease or determine a state of health. The US Food and Drug Administration (FDA) regulates investigations involving IVDs under the investigational device exemption (IDE). To support this work, IRBs must recognize when a study is using an IVD that is investigational, and determine whether it meets the criteria for an exempt device, a non-significant risk (NSR) device, or a significant risk (SR) device.

The rapid growth and application of genomic testing in clinical trials and the use of IVDs to select patients for drug trials, in particular, pose unique challenges for IRBs and investigators in this regard. IRBs, investigators, and sponsors often struggle with correctly identifying when an IVD is being used in a manner that makes it investigational, and correctly determining the risk level for the device.

During this webinar, presenters:

  • Provide an overview of FDA regulatory framework in relation to IVDs
  • Explain the application of IDE regulations to studies with IVDs
  • Highlight complex IRB scenarios and share processes developed by one institution through the use of case studies

Participation in this 90-minute webinar counts as 1.5 CE credit hours.

DHHS and FDA Regulations: What's Different, What's Similar, and What Does it all Mean for my HRPP?

2011

Speakers: Lisa Buchanan, MAOM and Richard Klein

DHHS and FDA Regulations: What’s Different, What’s Similar, and What Does it all Mean for my HRPP? features a discussion between the representatives of these two federal agencies.

Topics include:

  • Background information about the reasons for, and historical underpinnings of, the two sets of federal regulations
  • Overview of the U.S. Department of Health and Human Services (DHHS) regulations and recent guidance documents, including how they apply to research conducted internationally
  • Areas of overlap and divergence between the regulations of DHHS and the US Food and Drug Administration (FDA), and guidelines for determining which are applicable to the different kinds of research conducted at your institution

Participation in this 90-minute webinar counts as 1.5 CE credit hours.

Investigator-Initiated Device Studies: How IRBs Can Help Researchers Work With the FDA

2014

Speakers: Owen Faris, PhD, Soma Kalb, PhD, and Matthew Wladkowski, MS, RAC

US Food and Drug Administration (FDA) approval of an investigational device exemption (IDE) is required for studies of significant risk devices that involve human subjects and are not approved or cleared for the indication being studied. The process of applying for an IDE can be challenging for institutional review boards (IRBs) and investigators.

In most academic centers, investigators rely on IRBs for guidance with the IDE submission and approval process. This webinar provides the tools for determining whether an IDE is necessary, charting a timeline for the application process, and identifying the respective responsibilities of investigators and IRBs. The webinar covers the following topics:

  • Is an IDE needed?
    To assist the investigator in making this determination, the IRB needs to understand the goals of the study and whether the proposed research presents significant risk.
  • Application process
    If it is determined that an IDE is needed, IRB review must focus on the unique characteristics of device studies. Presenters highlighted the distinctions between device and drug studies as they pertain to IRB and FDA review, and identify key pieces of information that investigators need to present to the IRB and/or include in an IDE submission to FDA.
  • Deciphering the FDA decision letter
    The FDA decision letter will fully approve, approve with conditions, or disapprove the IDE. Presenters reviewed each of these potential decisions and offer insight into their implications.
  • Role of the IRB in the subsequent steps
    If the IDE is approved with conditions or disapproved, FDA’s decision letter will ask the investigator to respond to certain questions. If the IDE is fully approved, the sponsor may begin enrollment in the study without being subject to such requirements. The presenters discussed how IRBs can assist investigators in preparing responses to FDA as well as in successfully initiating the IDE study.

Participation in this 90-minute webinar counts as 1.5 CE credit hours.

Access Webinar Bundles

Webinar bundles are available to individual PRIM&R members at no cost. For a fraction of the cost of this bundle, become a member to watch the included webinars and gain dozens of other member benefits. 

Nonmembers can purchase individual or group access to this webinar bundle using the order form below. Each webinar is also availalbe individually. 

Already a PRIM&R member? Log in using the button at the top right of the screen for access to webinar bundles.

Individual nonmember rate: $750

Group nonmember rate: $1,550