7:30 am - 8:00 am Registration
8 am- 10:00 General Session (includes two short breaks)

• Introduction: Meeting Overview: Why are we here? (Barbara Buch)
• Brief Overview of FDAAA as it relates to pediatric research: (Lynda Ulrich)
• Embryology: Growth and Development: Vulnerabilities/considerations at each stage (Judith Cope)
• Clinical Trial Strategies to consider: Statistical Perspective (Donald Berry)
• Patient Protection Issues and Ethics of Pediatric Research (Michelle Roth-Cline)
• Patient Reported Outcomes - role in Pediatric Studies (Steven Hirschfield)
• Parent/Caregiver Perspectives Overview and Points to consider (Loice Swisher)

10:10- 11:30 Introduction to small group topics: Unmet Needs and Small Group Discussion topics (Invited Moderators or ODE representatives will give introduction)

• Musculoskeletal Disease (Michael Vitale)
• Cardiovascular Disease (Robert Vincent)
• Abdominal and GI diseases (Evan Nadler)
• Neurologic Disorders (Shenandoah Robinson)
• Renal Diseases (Michael H. Hsieh)
• Audiologic Disorders (Arthur Boothroyd)
• Diagnostics for pediatric patients: Challenges (Arleen Pinkos)

11:30-12:15 Opportunity for Public to comment

• Kathy Jenkins
• Robert Cambell

12:15-1:15 Lunch (on your own)
1:30 -5:30 Six Subspecialty Break Out Sessions (includes two short breaks)

Musculoskeletal Disease

• Akbarnia Growing Rods Part 2 Final
• Blakemore-Growing Rods Part 1
• Campbell VEPTR Story
• McCarthy- The Plea
• Pediatric Clinical Trials Small Group Discusssion
• Vitale-Ortho Surgeon Perspective

Cardiovascular Disease

• FDA clinical trials
• Small Group Questions

Abdominal and GI diseases

• FDA Conference-Probiotics IND Experience
• Hsieh-Intro Urology-Nephrology
• Nadler

Neurologic Disorders

• Alterman
• FDA Pediatric Clinical Trials Workshop
• FDA Workshop on Pediatric Clinical Trials for Devices
• Pediatric Medical Device Slides PENA SANS
• Small Group Questions

October 30
8:00-9:50 am Wrap up Subspecialty Breakout sessions
10-11:30 am Breakout topics Report Out- Recommendations in outline format by specialty

Musculoskeletal Disease (Michael Vitale)
Cardiovascular Disease (Robert Vincent)
Abdominal and GI diseases (Evan Nadler)
Neurologic Disorders (Shenandoah Robinson)
Renal Diseases (Michael H. Hsieh)
Audiologic Disorders (Arthur Boothroyd)

11:30-12 pm Conclusions/Common issues- Next steps