Impact of Paediatric Legislation on Regulatory Strategy Information Day.

Ivowen recently attended Topra’s Reviewing the Impact of Paediatric Legislation on Regulatory Strategy Information Day.


On the morning of the solar eclipse the clouds may have left us feeling disappointed, however the silver lining was definitely the frank and honest presentations regarding the PIP legislation which followed that day.


Paolo Tomasi, Head of Paediatric medicines in the EMA, confirmed that the number of modifications on agreed PIPs seem to decreasing due experience gained in recent years. He went on to clarify that it is not legally possible to have a clock-stop in a PIP Modification application and advised the applicant should withdraw and resubmit.


He clarified that

  • multiple PIPs are possible for separate conditions but not for indications, and that applicants can use MedDRA to identify a suitable condition; and
  • that waivers apply only for specific medical conditions and must be justified using  strong scientific and medical rationale


Pamela Dicks, Manager at the Scottish Children’s Research Network discussed the benefits of Networks and demonstrated how Patient Information Sheets, Consent Forms, etc., can be age appropriate through the use of appropriate graphics, language and terminology.


Ivowen can help you with your Paediatric Investigation Plan applications and modifications. Please contact us for further information.


Written by Fiona Downey