Vaccine Pathways to Market

Once the vaccine sponsor believes it has generated sufficient data to meet FDA’s safety and effectiveness requirements, the sponsor can submit a Biologics License Application (BLA) or request for an Emergency Use Authorization (EUA)(when appropriate) to FDA. This session will describe these procedures, as well as the rigorous process FDA uses to review the data in consultation with the Vaccines and Related Biological Products Advisory Committee (VRBPAC). We will also discuss other considerations such as the role of other government entities and post-approval pharmacovigilance. The illustration of COVID-19 vaccines in relation to this process will also be discussed.

  1. BLA Standard
  2. EUA Standard
  3. Role and Process of VRBPACVa
  4. Role of Other Government Entities
  5. Post-Approval Pharmacovigilance

 

Colleen M. Heisey, Partner, Jones Day

This session was recorded as part of FDLI’s Virtual Fundamentals of Vaccine Regulation Course in February 2021. 

 

 

Get Access

$99
  • +$100 for nonmembers

Virtual Learning FAQ

On-demand webinar content is sent via email as soon as we are able to process and verify your order. This usually occurs within 1 business day.

 

On-demand content can be played back on most devices.

If you have concerns, please click the Test Your System link to determine your device's compatibility, as well as system requirements. 

CLE credit is not currently available for pre-recorded sessions.

Related Content