How to initiate EU Paediatric Plans – Regulatory Strategy & Writing

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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