Regulatory Affairs

Office of the Vice President and Innovation

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Real Life Film Series: The Bleeding Edge

October 15, 2019 from 12:10 PM to 1:00 PM Tompkins McCaw Library, Lecture Room 2-010 (509 N. 12th St., Richmond, Va. 23298) Students, faculty, staff and health professionals are invited to the screening of the engaging documentary, The Bleeding Edge. Look at the unforeseen consequences of advanced technological devices used in the medical field. Then join […]

Recently Posted FDA Guidance Documents

9/27/2019 – Clinical Decision Support Software [DRAFT] The Food and Drug Administration (FDA) has long regulated software that meets the definition of a device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), including software that is intended to provide decision support for the diagnosis, treatment, prevention, cure, or mitigation of diseases […]

Sept. 19: Live Webcast – Privacy and Health Research in a Data-Driven World

Thursday, September 19, 2019, 8:15AM-4:15PM EDT This webcast is free of charge and no advance registration is required. You will be able to view the event at on 9/19. The U.S. Department of Health and Human Services Office for Human Research Protections (OHRP) is hosting its 2nd Annual Exploratory Workshop on September 19, 2019. It will explore […]

Oct. 9 & Oct. 11: Crucial Conversations with the IRB Part II (CReSS Workshop)

Crucial Conversations with the IRB, Part II: “Oops we did it again” Unanticipated Problems, Non-compliance Register for only one of the following two sessions: Wednesday, Oct. 9, from 9 – 10:30 am; MMEC 12‐101/102 Friday, Oct. 11, from 2:30 – 4 pm; MMEC 12‐101/102 The VCU IRB will continue their conversation with research teams in […]

Oct. 21: Webinar – Humanitarian Device Exemption Program

Date: October 21, 2019 Time: 12:00 PM EDT-01:30 PM EDT Registration is not necessary. On Monday, October 21, 2019, the FDA will host a webinar for device manufacturers and industry to discuss and answer questions about the Humanitarian Device Exemption Program Final Guidance published on September 5, 2019 This final guidance describes how the FDA determines whether […]

Recently Posted FDA Guidance Documents

9/6/2019 – Humanitarian Device Exemption (HDE) Program: Guidance for Industry and Food and Drug Administration Staff FDA developed this guidance document to provide clarity to industry and FDA staff about the current review practices for the Humanitarian Device Exemption (HDE) Program. This programmatic guidance addresses commonly asked questions about HDEs and Humanitarian Use Devices (HUDs), including FDA actions […]

Recently Posted FDA Guidance Documents

The Center for Devices and Radiological Health (CDRH) posted these new items on on August 29, 2019. To view listings for other dates, see CDRH New – News and Updates. Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions This guidance document describes the Food and […]

Regulatory Education for Industry (REdI): Clinical Investigator Training Course

November 12-14, 2019 The Hotel at the University of Maryland, College Park, MD The course fee is $500 and includes attendance to program sessions, coursebook with all speaker slides, breakfast on November 12-14, and daily refreshment breaks. A room block is available for the rate of $179/night This course provides a study of clinical trial […]

Using DNA/RNA as Drugs: From Discovery to Development

Monday, September 9th, 12:00 to 1:00pm Main Hospital – Learning Center (Main Hospital, first floor, across from the cafeteria), MCV Campus Please join us for the Wright Center for Clinical and Translational Research’s Discovery Dialogues seminar, “Using DNA/RNA as Drugs: From Discovery to Development,” presented by Wright Center Clinical Research KL2 Scholar Guizhi (Julian) Zhu, Ph.D. Faculty, staff, students, patients, and families […]

September’s Journey to Impact presentations from the “Beyond the Bench” Workshop Series

Journey to Impact: Dr. Horn-Ranney Fri. September 6th, 12:00 – 1:00 PM Main Hospital – M2 – Room 2-125 Hear from Dr. Horn-Ranney (CEO of Tympanogen) about founding her medical device company, navigating the transition from academia, and the importance of research commercialization Journey to Impact: Dr. Eric Edwards Fri. September 20th, 12:00 – 1:00 PM Main […]

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