Regulatory Open Forum

 View Only

Pediatric Investigation Plan (PIP)

  • 1.  Pediatric Investigation Plan (PIP)

    Posted 04-Oct-2019 15:06
    Hello Everyone,

    Is it a requirement to write a Pediatric Investigation Plan (PIP) for a study involving both adult and pediatric subjects for a study in Canada?

    Would it be similar to the one required by the EMA? Reference: Pediatric Investigation Plan EMA

    Thank you,
    Brian C.

    ------------------------------
    Brian Cooney
    FL
    United States
    ------------------------------