FDA‒University of Maryland CERSI Co-sponsored Workshop

September 23, 2016

Objectives:

Master protocols that run continuously and evaluate numerous investigational products simultaneously are being used to expedite clinical trial investigations for many medical products. This workshop focused on pediatric master protocols.  The workshop provided a forum for discussion of the regulatory and scientific concerns of pediatric master protocols and clinical trial design considerations for these protocols.  Additionally, applications of pediatric master protocols to specific therapeutic areas had been discussed.

Agenda:

The agenda can be found on the University of Maryland CERSI Web page. 
 

Location:

Food and Drug Administration
White Oak Campus
The Great Room
10903 New Hampshire Ave.
Silver Spring, MD 20993

Recordings

• https://collaboration.fda.gov/p28gv8txmt9/
• https://collaboration.fda.gov/p4awnwvy2z2/
• https://collaboration.fda.gov/p11817w054a/