For The Consortium

Pediatric Drugs and Devices Meetings

CTSA Consortium Child Health Oversight Committee - Pediatric Drugs and Devices Special Interest Group
November 13, 2009
Meeting Materials  Agenda
 Meeting Summary

CTSA Consortium Child Health Oversight Committee - Pediatric Drugs and Devices Group
October 23, 2009
Meeting Materials  Agenda

CTSA Consortium Child Health Oversight Committee - Pediatric Drugs and Devices Group
September 11, 2009
Meeting Materials  Agenda
 Meeting Summary

CTSA Consortium Child Health Oversight Committee - Pediatric Drugs and Devices Group
July 10, 2009
Meeting Materials

CTSA Consortium Child Health Oversight Committee - Pediatric Drugs and Devices Group
June 12, 2009
Meeting Materials  Agenda
 Meeting Summary

CTSA Consortium Child Health Oversight Committee - Pediatric Drugs and Devices Group
March 13, 2009
Meeting Materials  Agenda
 Meeting Summary

CTSA Consortium Child Health Oversight Committee - Pediatric Drug and Medical Device Development Workshop
February 26, 2009
Meeting Materials  Agenda
  Meeting Recording
Presentations
Final Recommendations 
Final Recommendations
Overview of CTSA Program as Framework for Expectations 
The CTSA Collaborative Vision: Enhancing Pediatric Clinical Research
Anthony Hayward
Director, Division of Clinical Research Resources
NCRR
Purpose, Vision and Expected Outcomes 
Pediatric Drug & Medical Device Development: Setting Specifications & Defining Expectations
Carole Marcus
Director of Sleep Center
Children’s Hospital of Philadelphia
Current Status of U.S. Pediatric Clinical Research Infrastructure 
A Snapshot of Multi-Site Research Capacity
Mort Wasserman
Professor of Pediatrics
University of Vermont
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Clinical Research Programs 
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Clinical Research Programs
Anne Zajicek
Chief (Acting) Obstetric and Pediatric Pharmacology Branch
NICHD
U.S. Regulatory Framework for Pharmaceutical Development 
Pediatric Drug and Medical Device Development
Chair: Dianne Murphy
Director
FDA Office of Pediatric Therapeutics
What do large Pharmaceutical Companies expect and what can they offer? 
Pharmaceutical Industry Panel
Chair: Mary Christian
Co-Chair, Pediatric Drug Development Committee
Bristol-Myers Squibb
What do Biotechnology Companies expect and what can they offer? 
Biotechnology Companies Panel
Chair: Lawrence Grylack
PAREXEL Consulting
What do Medical Device Manufacturers expect and what can they offer? 
Medical Device Manufacturers Panel
Chair: Robert Campbell Jr
The Children’s Hospital of Philadelphia
What do Advocacy and Patient/Parent Groups expect and what can they offer? 
Advocacy and Patient/Parent Groups Panel
Chair: Ann Gettys
Children’s Interstitial Lung Disease Foundation
What do Nonprofit Organizations and Academic Investigators expect and what can they offer? 
Nonprofit Organizations and Academic Investigators Panel
Chair: Andre Muelenaer
Carilion Biomedical Institute
CTSA Consortium Meeting on Development of Pediatric Drugs and Devices: Expectations and Specifications 
Summary
Jennifer Li
Duke University

Pediatrics Oversight - Pediatric Drugs and Devices Workshop Planning Call
January 16, 2009
Meeting Materials

CTSA Consortium Child Health Oversight Committee - Pediatric Drugs and Devices Group
January 9, 2009
Meeting Materials