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From the Pediatric Case Files of FDA

Nov 6 2014 8:00AM - Nov 6 2014 11:30AM | Bethesda North Marriott Hotel and Conference Center 5701 Marinelli Road, North Bethesda, MD 20852 USA

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Overview 

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

Learning Objectives 

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

Contact Information 

Printable Registration Form

Registration Questions
Toll Free 1.888.257.6457
Phone +1.215.442.6100
Fax +1.215.442.6199
Monday-Friday 8:30AM-8:00PM ET
CustomerService@diahome.org

Agenda Details
Meredith Kaganovskiy, Content Lead
Phone +1.215.442.6117
Fax +1.215.442.6199
Meredith.Kaganovskiy@diahome.org

Event Logistics
Stephanie Ritter, Event Planner
Phone +1.215.442.6149
Fax +1.215.442.6199
Stephanie.Ritter@diahome.org

Instructor(s) 

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Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.

Participants with Disabilities:
Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact the DIA office in writing at least 15 days prior to event to indicate your needs.

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