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CRM Webinar: COVID-19 and the US Response in Accordance with Regulations

COVID-19 has had an immense impact on health and healthcare related issues in the US and globally. John G. Risk, Clinical Pharmacist and recent graduate of the Clinical Research master's program, will cover COVID-19 and the US response to it (pharma, FDA, administration, etc.) Topics in this webinar include:

  • What is expanded access or compassionate drug use?
  • Expanded access versus Emergency Use Authorization
  • Expanded access criteria
  • Do all patients who meet criteria qualify for expanded access?
  • Types of expanded access
  • Gaps and challenges with the current system
  • The first part of the webinar will be a presentation and review, followed by open discussion. From this webinar, attendees will better understand FDA regulatory pathways to facilitate drug access, define and differentiate expanded access and emergency use authorization, identify patients eligible for expanded access, and list examples of drugs granted expanded access or emergency use authorization.

About the speaker

John earned his Bachelor of Science in Pharmacy from the Lebanese American University – School of Pharmacy, and then went on to earn his master's in Clinical Research Management from Arizona State University, where he was awarded ASU's Outstanding Research Award in March 2020. Published articles include Pharmaco-Immunomodulatory Therapy in COVID-19, Anticoagulation Management Strategies in Heart Transplantation, and Novel Approaches to Management of Hyperkalemia in Kidney Transplantation. John currently works for Bellevue Medical Center in Sarpy County, Nebraska, as a Hospital & Clinical Pharmacist.

Events Details

Wednesday, October 21, 2020 - 10:00am to 11:00am
Price: Free