News & Events

Public Workshop- Advancing the Development of Pediatric Therapeutics (ADEPT): Successes and Challenges of Performing Long-Term Pediatric Safety Studies

The Food and Drug Administration (FDA) is announcing a public workshop entitled “Advancing the Development of Pediatric Therapeutics (ADEPT): Successes and Challenges of Performing Long-Term Pediatric Safety Studies”.

The purpose of this two day workshop is for FDA to have an open discussion with experts in the field regarding the length of pediatric safety studies. Day 1 will focus on an exposition of the successes and challenges of long-term safety studies in children. Day 2 will focus on suggestions for the future on study design and implementation for long-term safety studies in children. Viewpoints of patient representatives of children with long-term conditions and industry will be included.

Date:
April 13-14, 2016

Time:
8:00 a.m. to 5:00 p.m.

Location:
DoubleTree by Hilton Hotel - Bethesda
8120 Wisconsin Avenue, Bethesda, Maryland 20814

Registration:
To register for this workshop, visit the workshop registration page disclaimer icon

Seating will be limited so please register before close of business on April 7, 2016.

Workshop Materials:

  • Federal Register Notice
  • Final Agenda
  • Panelists
  • Speakers' Biographies
  • Presentations
    The slides for all the presentations will be posted on the website either before or shortly after the workshop. Paper copies of the presentations at the workshop will be limited. Please plan for access to the presentations during the workshop via computer if possible.
     
  • Transcripts (will be posted after the workshop)

Webcast:

April 13

  • Morning session webcast disclaimer icon
    After the morning session, users will be automatically redirected to the afternoon link. Should you lose connection over lunch, please use the following link for the afternoon session. (Note: it is different from the morning's session)

April 14

  • Morning session webcast disclaimer icon
    After the morning session, users will be automatically redirected to the afternoon link. Should you lose connection over lunch, please use the following link for the afternoon session. (Note: it is different from the morning's session)

For questions regarding the workshop please contact:
Renan A. Bonnel Pharm.D, MS, MPH
Office of Pediatric Therapeutics
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993–0002
301-796–8654
FAX: 301–847–8640
email: renan.bonnel@fda.hhs.gov

Page Last Updated: 04/15/2016
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