Author: estoddert

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 […]

2019 Mid-Atlantic Interprofessional Leadership Conference

Friday, October 18, 2019, 7:30 AM – 5:00 PM Richmond Marriott Downtown, Richmond, VA  Registration ($145-155) Target Audience: Multiple Specialties, Nurse Practitioner, Nursing, Nutrition, Physical Therapy, Physician Assistant, Social Work, Speech Language Pathology  Overview: The 16th Annual Mid-Atlantic Interprofessional Leadership Conference, with a theme of “Leading the Way” in team-based care, is specifically designed to […]

ACRP Annual 2019 Fall Symposium

November 1, 2019, from 07:30 AM – 05:00 PM The University of Virginia, Darden School of Business, Abbott Auditorium 100 Darden Boulevard, Charlottesville, Virginia 22903 Cost from $100 (Early-Bird Chapter Member rate) -$210 (Non-Member Registration with Contact Hours) This full-day event will allow you the opportunity to earn up to 7.5 educational contact hours and […]

IEEE EMB Special Topic Conference on Healthcare Innovations and Point-of-Care Technologies

November 20-22, 2019 NIH Natcher Conference Center, Bethesda MD Registration ($0-$675) The sixth annual IEEE EMB Strategic Conference will focus on point-of-care technologies (POCT) for healthcare, emphasizing funding opportunities and the promise and pitfalls of the journey from idea to the patient. The conference will provide a strategic forum in which clinicians, industry experts, […]

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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