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Are You Prepared to Address Pediatric Plan Requirements?

Are You Prepared to Address Pediatric Plan Requirements?
13 October 2017

Did you know that pediatric plans are a requirement for virtually all new medicines, and not just those that are identified as available for children? The only exceptions are those medicines that are on the waiver list or are exempted by the FDA or EMA.

More stringent pediatric requirements were set in place in both the U.S and EU to make more medications more safely available to young patients and provide better information on them to caregivers.  Despite the fact that some labeling requirements for children existed since 1979, more than 80 percent of listed medication labels didn’t have prescribing information for children and were being used off label (even in hospitals)—a potentially hazardous situation that the FDA and EMA sought to rectify.

Pediatric investigation plans (PIPs) are the EU Pediatric Regulation’s main tool to ensure that previously unmet therapeutic needs in children are researched and appropriate medicines are developed. Pediatric study plans (PSPs) are required by the FDA in the U.S. to identify needed pediatric studies early in drug development. Since PIP and PSP adoption, more medicines have been made accessible to children and better information is available regarding their usage.

Requirements indicate that not filing PSPs and PIPs properly or on time could prevent Marketing Authorization Applications (MAAs) and New Drug Applications (NDAs) from being evaluated.

What do you need to know about the evolution of pediatric trials and how pediatric plan requirements could impact your clinical development?

Synteract’s vice president for global medical and regulatory affairs, Dr. Martine Dehlinger-Kremer, will speak on this very topic at several upcoming opportunities, including:

  • DIA/EFGCP/EMA Pediatric Conference on “How To Optimize Children’s Access To Innovative Medicines”; member of programme committee & session chair for “How To Optimize Drug Development Up To Approval And Beyond”, Oct 17-18, London, UK
  • 1st Kiev Clinical Research Forum, advisor and opening remarks, presenting “Pediatric Research: Where Are We Today?”, Nov 9-10, Kiev, Ukraine
  • Pediatric Drug Development Conference, presenting “The New Clinical Trials Regulation In The Context of Pediatric Research”, Nov 13-15, Budapest, Hungary

Dr. Dehlinger-Kremer knows the subject matter! She is the chair of the European Forum for Good Clinical Practice (EFGCP) Children’s Medicines Working Group, chair of the European CRO Federation (EUCROF) Pediatric Working Group and member of Working Parties of Enpr-EMA, the European Network of Pediatric Research at the European Medicines Agency.

Please contact us for more information on how we can help you.


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