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.
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.
- Affiliation, Company or Organization
- E-mail address
- Telephone number
- Federal Register Notice
- Draft Agenda (PDF - 80KB)
- Speaker List(PDF - 126 KB)
- Speaker Biographies
- Pediatric Product Development and the FDA: What does the "F" stand for? by Lynne P. Yao, M.D.
- Pediatric Extrapolation by Hari Cheryl Sachs, M.D., F.A.A.P.
- Pediatric Extrapolation FDA Approach by Dianne Murphy, M.D., F.A.A.P.
- Small Clinical Trials by Anne Pariser, M.D.
- What Do You Need to Know About the Special Protections for Pediatric Subjects? by Robert "Skip" Nelson, M.D., Ph.D.
- What Do We Look For To Support Pediatric Dosing? by Lily Mulugeta, Pharm.D.
- Innovation, Challenges and Lessons from the Pediatric Trials Network by Brian Smith M.D., M.P.H., M.H.S.
- Assessing Pre-Market Safety in Pediatric Drug Development: The DAVP Perspective by Linda L. Lewis, M.D.
- Gathering Adequate Clinical Trial Data for the Postmarketing Safety Database by Andrew D. Mosholder, M.D., M.P.H.
- Key Elements of Statistical Analyses for Studies with Small Populations (Pediatrics) by Lisa A. Kammerman, Ph.D.
- Pediatric Dosage Development: Where Are We? by Julia C. Pinto, Ph.D.
- What is GCP? How to Survive an FDA Inspection by Susan Leibenhaut, M.D.
- Pediatric Product Development: Nonclinical Studies by Melissa S. Tassinari, Ph.D., D.A.B.T.
- FDA’s Written Requests and the NIH Process: Changing from Reactive to Proactive by Dianne Murphy, M.D., F.A.A.P.
- NIH Real-Life Experiences - Clinical Investigator Training Workshop by Anne Zajicek, M.D., Pharm.D.
- Global Network Collaborations by Jonathan Davis, M.D.
- 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,
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: firstname.lastname@example.org.
For additional information on pediatrics please go to: www.fda.gov/pediatrics