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Author: komornikea

FDA Videos on Patient Engagement and Medical Devices

The U.S. Food and Drug Administration (FDA) released three videos highlighting patients’ experiences in partnering with the FDA and how patient input enhances the agency’s ability to evaluate medical devices and monitor their safety. The videos are: FDA Devices: Our Commitment to Putting Patients First FDA Devices: Welcoming Patient Voices Today and Every Day Medical […]

VCU Human Research Protections Program Holiday Schedule

Thanksgiving Holiday The Human Research Protection Program (IRB) office will be closed for Thanksgiving beginning at noon on Wednesday, 11/25/20 and will reopen on Monday, 11/30/20. Investigators remain responsible for reporting to the IRB any unanticipated problems involving risk to subjects or others that occur during this time.  For guidance on what constitutes an unanticipated problem, refer to […]

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 […]

Diversity in Clinical Trials: Learn about Enrollment Trends and Resources from FDA

Join the CDER Small Business and Industry Assistance webinar Diversity in Clinical Trials: Learn about Enrollment Trends and Resources from FDA December 16, 2020 | 1:00 – 2:30 p.m. Eastern FREE Registration In this era of globalization, meeting various regulatory authorities’ expectations in recruitment of diverse trial population is challenging. The need for faster drug […]

CDER SBIA Regulatory Education for Industry (REdI) Annual Conference 2020 Recordings

Recordings and slides are available for the 2020 REdI Annual Conference. Day One  Real-world Evidence for Drugs, Biologics, and Devices So, Your NDA Was Approved – Now What?! Post-approval Responsibilities Obligations Restructure of the Office of New Drugs (OND) Overview of Postmarketing Drug Safety Reporting Requirements Enhanced Drug Distribution Security – DSCSA Implementation Updates Drug […]

FDA Offers Guidance to Enhance Diversity in Clinical Trials, Encourage Inclusivity in Medical Product Development

The final guidance issued on November 9th, “Enhancing the Diversity of Clinical Trial Populations–Eligibility Criteria, Enrollment Practices, and Trial Designs,” was first issued as a draft in 2019. It provides the FDA’s current thinking on steps to broaden eligibility criteria in clinical trials through inclusive trial practices, trial designs, and methodological approaches. The guidance aims […]

VCU Health’s arts in healthcare week

Dance Your PhD! Contest

The 13th annual Dance Your Ph.D. contest, hosted by the American Association For The Advancement of Science and Science Magazine, is now accepting submissions. Details on how to enter and rules for submissions can be found on the contest’s website.  If you can turn the question “What’s your Ph.D. research about?” into a dance, you could win prizes!

Apply now for February 2021 PCRC Palliative Care Clinical Trials Intensive

This three-day intensive seeks to provide a foundation in practical aspects involving the conduct of randomized clinical trials in palliative care. It is designed for early career researchers or other mid-career researchers and health professionals interested in developing competence in the planning, design, and execution of randomized clinical trials. Instruction will include a combination of […]

VCU Health system COVID-19 information – clinical research team members

In response to the Virginia Occupational Safety and Health (VOSH) Program and Virginia Department of Labor and Industry (DOLI) Emergency Temporary Standard related to COVID-19, VCUHS is providing education on PPE requirements and risks associated with COVID-19 transmission on the VCU Health COVID19 Intranet Site. Please complete the following RedCap survey if possible. Link:   https://redcap.vcu.edu/surveys/?s=E4RPFDNN3F

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