Division of Clinical Research

Office of the Vice President and Innovation

Category results for: Workshop

FDA Virtual Workshop – February 16-17, 2021

FDA Virtual Workshop: Evaluating RWE from Observational Studies in Regulatory Decision-Making  The U.S. Food and Drug Administration and the Duke-Margolis Center for Health Policy will hold a two-day virtual workshop on February 16-17, 2021, focused on considerations about observational (non-interventional) study design and conduct when using evidence from observational studies to inform regulatory decisions.     FDA defines real-world evidence (RWE) as the clinical evidence regarding a medical product’s […]

Healing/Arts Workshop with Caren Beilin

A  virtual Healing/Arts workshop featuring experimental writer and health activist Caren Beilin will take place on Thursday December 10 at 4pm est. Caren will talk about her most recent book Blackfishing the IUD (Wolfman; 2019), a collaboratively-written memoir about reproductive health and the IUD, gendered illness, medical gaslighting, and activism in the chronic illness community. And she will […]

FDA CDER Meetings, Conferences, and Workshops: October-November 2019

October 2019 PQRI BTC 2019 Webinar Series: Holistic QbD to Enable Product Quality; Oct. 10 @ 10:30 am EDT SBIA Webinar: Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) using International Council for Harmonisation (ICH) E2B(R3) Standards; Oct.11 @ 1 pm EDT Antimicrobial Drugs Advisory Committee Meeting; Oct 16; Silver […]

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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