Topic:  Review of Key FDA (CDER) activities in 2023

Speaker: Merrie Mosedale, PhD, RAC  Regulatory Science Lead, UCB Biosciences

This talk will provide an overview of key FDA activities relevant to biopharmaceutical development from 2023. Important guidances, proposed rules, new programs, and other FDA actions will be discussed. Attendees will benefit from seeing key trends in Agency activities from the past year as well as a discussion of specific details important to regulatory professionals working in the biopharmaceutical sector.

 SPEAKER BIO:

Merrie Mosedale is a Regulatory Science Lead within Global Regulatory Affairs at UCB Biosciences Inc., where she is responsible for regulatory activities related to product development and marketing authorization in the US. Mosedale is also a member of the UCB Regulatory Intelligence Team where she contributes to surveillance, communication, and assessment of US regulatory information.  Prior to joining UCB, Mosedale was an assistant professor and program team lead developing regulatory studies training opportunities at UNC Chapel Hill, and she continues to support regulatory science research and education as an adjunct assistant professor in the UNC Eshelman School of Pharmacy.

EVENT LOGISTICS:

For in-person attendees, there is a networking reception from 5:30-6:30.  
PLEASE NOTE: onsite registration is closed as of 26-Feb; sorry but we have reached capacity for the space; remote/Zoom registration is still available.

The hybrid seminar presentation will be held from 6:30-8, including an open floor for audience questions. 
Thank you to UCB for generously providing the event space to support this educational forum! **PLEASE NOTE NEW LOCATION!!**

Register for this event below. The event is free for all NCRAF members (standard as well as student/post-doc/unemployed jobseeker); for non-members, registration is $20.

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