Mock PeRC is now in session!
Tutorial participants will have an opportunity to present a case at a “mock” PeRC meeting to panelists who are ACTUAL PeRC members.
Ever wondered why FDA granted a waiver under PREA for one product but required studies under PREA for a similar product? Join FDA for a stimulating and challenging tutorial about issues related to pediatric product development. Cases will be presented that illustrate a variety of common and not-so-common situations that the Agency has addressed in pediatric product development since the passage of BPCA and PREA. FDA will guide the discussion but audience participation is requested!
Who Should Attend
This tutorial is designed for all stakeholders interested in the development of products used to treat pediatric patients. If you are interested in maximizing the efficiency of a pediatric development program, please join our FDA colleagues and experienced experts to gain insight and understanding of pediatric product development as illustrated by the cases presented.
Click on the link for more information regarding our Pediatric Research Conference 2014
At the conclusion of this tutorial, participants should be able to:
- Compare past and current FDA decision making relevant to pediatric product development under BPCA and PREA
- Discuss various scientific, clinical, and regulatory nuances related to pediatric product development under BPCA and PREA