How to initiate EU Paediatric Plans – Regulatory Strategy & Writing

Human Human behavior
October 21, 2020
60min
  • Drug Development
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Our experts at BlueReg are covering the different aspects of the Paediatric Plan, specific to the European Market.

The different subjects covered are :

 

1. Regulatory Strategy

 

  • Why do we need an EU Paediatric Plan?
  • Is a PIP required?
  • Plan the PIP procedure
  • Overview of the PIP procedure
  • Which PIP condition?
  • Should the PIP include a paediatric development, a waiver and/or a deferral?
  • Content of the PIP Application

 

2. Writing the Paediatric Scientific Document

 

  • Application Summary
  • Overall Development
  • Product-Specific Waiver(s)
  • Paediatric Investigation Plan
  • Deferral(s)
  • References

 

3. Q&A’s

 

 

 

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