FDA Announces Public Workshop on Pediatric Clinical Investigator Training

Public Workshop – Pediatric Clinical Investigator Training

The Food and Drug Administration (FDA) is announcing a public Workshop entitled “Pediatric Clinical Investigator Training.”

The purpose of this workshop is to provide investigators with training and expertise in designing and conducting clinical trials in pediatric patients that will lead to appropriate labeling. The training course is intended to provide investigators with: 1) a clear understanding of some of the challenges of studying products in the pediatric population when the data is intended to be used to support product labeling, 2) an overview of extrapolation as it relates to the pediatric population, 3) a familiarity with FDA processes and timelines that are specific to pediatric product development, and 4) an overview of ethically appropriate methods related to the design of clinical trials in the pediatric population.

Date: September 22, 2014 Time: 8:00 a.m. to 5:30 p.m. Location: Pooks Hill Marriott 5151 Pooks Hill Road Bethesda, MD 20814

Registration to Attend the Workshop:

If you wish to attend this Workshop, you must register by submitting a written request with the information listed below to OPT@fda.hhs.gov before close of business on September 8, 2014.

1. Name

2. Title

3. Affiliation, Company or Organization

4. E-mail address

5. Telephone number

Workshop Materials:

Federal Register Notice
Speaker Biographies (to be posted at a later date)
Presentations (to be posted at a later date)
Videocast (to be posted after the workshop)

For questions regarding the workshop content please contact:

Terrie L. Crescenzi, RPH, Office of Pediatric Therapeutics, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 301–796–8646, FAX: 301–847–8640, email: terrie.crescenzi@fda.hhs.gov.

Betsy Sanford, Office of Pediatric Therapeutics, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-8659, FAX: 301-847-8640, email: elizabeth.sanford@fda.hhs.gov.

For additional information on pediatrics please go to: