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Final Agenda for the May 11, 2011 Meeting of the Pediatric Ethics Subcommittee of the Pediatric Advisory Committee


Wednesday, May 11, 2011
Bethesda North Marriott Hotel,
5701 Marinelli Rd,
Bethesda, Maryland, 20852

8:00 a.m.

Welcome and Introductory Remarks

Jeffrey Botkin, MD,
Chair of Pediatric Ethics Subcommittee
Professor of Pediatrics
Adjunct Professor of Medicine
University of Utah

 

Walter Ellenberg, PhD
Executive Secretary, Pediatric Advisory Committee
Office of Pediatric Therapeutics, OC, FDA

8:05 a.m.

Agenda Overview

Robert 'Skip' Nelson, MD, PhD
Senior Pediatric Ethicist/Lead Medical Officer
Office of Pediatric Therapeutics, OC, FDA

8:15 a.m.

Phenotyping Studies in Children:
Why, How and Issues to be Addressed

J. Steven Leeder, MD
Division Chief Clinical Pharmacology
Children’s Mercy Hospitals and Clinics

 

Opportunity for questions

 

9:00 a.m.

Evaluating Exploratory IND Studies According to the Ethical Framework of 21 CFR 50 subpart D

Robert 'Skip' Nelson, MD, PhD
Senior Pediatric Ethicist/Lead Medical Officer
Office of Pediatric Therapeutics, OC, FDA

 

Opportunity for questions

 

9:45 a.m.

Break

 

10:00 a.m.

Presentation of Questions

Michelle Roth-Cline, MD. PhD
Pediatric Ethicist/Health Scientist
Office of Pediatric Therapeutics, OC, FDA

 

Committee Discussion

 

11:00 a.m.

Open Public Hearing

 

12:00 p.m.

Lunch

 

1:00 p.m.

Discussion and Recommendations

 

3:00 p.m.

Adjourn

Jeffrey Botkin, MD, Chair
Professor of Pediatrics
University of Utah