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U.S. Department of Health and Human Services

Medical Devices

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FDA Pediatric Clinical Trials Workshop: Unmet Needs, Trial Designs and Clinically Meaningful Safety and Effectiveness Outcomes, October 29-30, 2009

This public workshop is intended to solicit information about and gain perspective from health care providers, academia, and industry on various aspects of clinical trials involving pediatric diseases and patients. Specialty Discussion topics include:

  • Pediatric Musculoskeletal Disease
  • Pediatric Cardiovascular Disease
  • Pediatric Abdominal and GI diseases
  • Pediatric Neurologic Disorders
  • Pediatric Genitourinary Diseases
  • Pediatric Speech and Audiologic Disorders and
  • Diagnostics for pediatric patients: Challenges

Date, Time and Location

The meeting will be held on October 29, 2009 from 8:00 a.m. to 5:30 p.m. and October 30, 2009 from 8:00 a.m. to 12:00 noon at the following location:

Holiday Inn College Park 
located off of I-95 at 
10000 Baltimore Ave
College Park, MD 20740

The hotel front desk number is: 1-301-345-6700.

Information about discount room rates may be found at www.holidayinncollegepark.com; then enter Group Block code FPT to get the discounted rate for a limited block of rooms reserved for workshop participants.

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October 29th

8:00-10:00General Session (includes two short breaks)
10:10–11:30Introduction to small group topics: Unmet Needs and Small Group Specialty areas
11:30-12:15Opportunity for Public Speakers to comment (will be pre-approved)
12:15-1:15Lunch (on your own)
1:30-5:30Break Out Sessions (includes two short breaks)
These will consist of focused subspecialty discussions led by a moderator and panelists who are experts in each specialty area and will focus on the discussion questions posed in the FR notice.

October 30th

8:00-9:50Wrap up Breakout sessions
10:00-11:30Breakout topics Report Out- Recommendations in outline format
11:30-12:00Conclusions/Common issues- Next steps

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Information about registration can be found at:


There is no cost for registration, however you must register to participate so that adequate seating may be available. Registration will begin after September 11.

Full information can be found in the Federal Register.

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The workshop organizer may be contacted at:

Barbara Buch, MD
email: Barbara.buch@fda.hhs.gov

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