New York New Jersey Chapter Webcast: EUA - From Authorization to Approval

1.0
RAC Credits
Tuesday, 26 January 2021 (12:00 PM) - Tuesday, 26 January 2021 (1:00 PM) Eastern Time (US & Canada)

Member: $10
Nonmember: $25

Description

The COVID-19 pandemic has fostered innovation in the regulatory and decision-making processes, and the adoption of new product development approaches to confront unique challenges. Learn about the unique regulatory considerations in transitioning from Emergency Use Authorization (EUA) to full product approval amid the COVID 19 public health emergency. With a focus on biopharmaceuticals, this presentation will cover key learnings from obtaining an EUA through filing a New Drug Application. There will be a Q&A session at the end. 

This event is brought to you by the RAPS New York/New Jersey Chapter to encourage knowledge sharing and community development. RAC holders may claim 1.0 RAC recertification credits.

Learning Level: Intermediate
 Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity. 

RAPS membership provides vital information for regulatory professionals, as well as a place for networking and invaluable connections. Now is a great time to explore the many benefits to RAPS membership, including the Member Knowledge Center and our award-winning, private online community, Regulatory Exchange. Find out more about RAPS membership today.

How Do Webcasts Work?

For the best webcast experience, please use the Google Chrome browser. RAPS webcasts are also mobile- and tablet-accessible for your convenience. Registrants will receive instructions on how to log in 24 hours before the start of the webcast. A live Q&A portion with the speaker will follow the presentation. 

Featured Speaker:
Ashley Rhoades, manager, regulatory affairs, Gilead Sciences