I’m developing a Paediatric Investigation Plan (PIP) and would like to know where I can ask for scientific advice. Which regulatory bodies or expert groups are the best to approach for guidance on designing and implementing a PIP?
We see a website from EMA on preparing PIPs, @violettegijsen do you have additional advice or guidance based on your experience with therapies for children?
Paediatric investigation plans: questions and answers | European Medicines Agency (EMA)
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Thank you for your patience. Indeed, you can ask scientific advice from the EMA themselves, which probably helps as you are close to the source who is also evaluating your PIP. However, I would recommend asking a paediatric clinical pharmacologist to help. This will improve the design of your PIP and might help solving problems before they arise. I’m not certain if there is an expert group for PIP specifically, but there are a lot of pediatric research networks in Europe that may help. One of these are ERN (European Reference Networks - European Commission) another one is the Conect-4-Children network (https://conect4children.org/).
Hopefully, these options will help.
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