Overview
No new drug or biological can be submitted for marketing authorisation in the EU in adults, without an agreed Paediatric Investigation Plan (PIP) or a waiver from the European Medicines Agency (EMA). The development of a paediatric strategy can be divided into the three phases;
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strategic preparation & homework
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the dialogue & negotiation procedure with the Paediatric Committee (PDCO) of the EMA
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follow-up activities including performing agreed studies & other measures, PIP modification(s), and finally the compliance check by EMA
The EU pediatric legislation is exposing drug developers to new requirements. Applicant and EMA / PDCO may have different opinions about the necessary development steps. If the applicant cannot agree a PIP or a waiver with the PDCO, a negative opinion is possible, which will require submission of a new PIP/waiver application . It is EMA / PDCO’S responsibility to ensure access to safe and effective new medicines for children, while not delaying or preventing marketing authorisation of new drugs for adults.
Who Should Attend
Associates in regulatory affairs, medical affairs and clinical operations and project management who will either deal with pediatric investigation plans (PIPs) or would like a get a hands-on feeling how they work
Learning Objectives
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Recognise the key challenges in negotiating a paediatric investigation plan or a waiver
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Identify key misunderstandings in the PIP negotiation procedure
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Evaluate options in the PIP dialogue with EMA / PDCO