WAYS of WORKING Podcast

WAYS of WORKING

WAYS Pharmaceutical Services
Regulatory submission professionals talking about all things regulatory. -What's the latest on electronic regulatory submissions? -What do I need to know about CDISC compliant data packages? -What are most teams doing to support Ad Promo submissions in eCTD format? We'll talk about trends, best practices, and emerging regulations. We'll also interview leaders from across the industry to share perspectives and lessons learned. Join us!
Emergency Use Authorizations During the COVID-19 Pandemic - Part 3
In this episode, Dr. Nancy Smerkanich provides an update from the recent Vaccines and Related Biological Products Advisory Committee Meeting. The Advisory Committee Meeting lasted 9 hours and Emergency Use Authorizations continued to be a high priority topic throughout the discussion. 
Nov 5, 2020
29 min
Emergency Use Authorizations During the COVID-19 Pandemic - Part 2
In this episode, we continue our conversation with Dr. Nancy Smerkanich, Assistant Professor at the University of Southern California School of Pharmacy. Dr. Smerkanich shares her insights into current Emergency Use Authorizations, how sponsors and the agency are interacting, and the expected pressures of developing, producing and distributing products during the pandemic. (Part 2)
Oct 26, 2020
22 min
Emergency Use Authorizations During the COVID-19 Pandemic
In this episode, we talk to Dr. Nancy Smerkanich, Assistant Professor at the University of Southern California School of Pharmacy about Emergency Use Authorizations (EUAs). Nancy describes what EUAs are and how they are being used in the current pandemic. (Part 1)
Oct 26, 2020
20 min