BlueReg Group Development Paediatric Investigation Plans (PIPs) Paediatric Investigation Plans and Pediatric Study Plans A Paediatric Investigation Plan (PIP) or Pediatric Study Plan (PSP) is a development plan intended to support the authorisation of a medicine for children by ensuring data are obtained through studies in the paediatric population. Our consultants can advise as to whether a deferral or waiver may be appropriate and can provide a complete PIP writing service as well as any PIP modifications through the lifecycle of the product within the EU or US. Europe In Europe, PIPs are described in Regulation (EC) No 1902/2006 which came into force in the EU on 26 January 2007. This paediatric regulation put in place the PIP to be agreed upon by a new expert committee (the Paediatric Committee [PDCO]); it also regulates a system of obligations and rewards and different transparency/information measures. The objectives are to improve and better protect the health of children with high quality & ethical research, increasing availability of appropriately authorised medicines for children specific information on the use of medicines in the paediatric population. United States In the US the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act ( PREA) are the basis of the paediatric US legal framework. The Pediatric review Committee (PeRC) was established by legislation to carry out the activities described under PREA and BPCA. The ultimate goal of PREA and BPCA is to develop new pediatric labelling to encourage the appropriate use of medications to treat pediatric patients. The outline of the pediatric studies the applicant plans to conduct will be compiled in the Pediatric Study Plan (PSP). How BlueReg can support your PIP/PSP strategy & development Our consultants can advise you in all steps of the preparation and design of your initial PIP/PSP: Assess the right strategy concerning the PIP/PSP scope and timelines to meet your objectives Agree on the right condition and indications to be studied through a systemic approach and rigorous methodology For all age subsets, assess whether a waiver and/or deferral options can be considered based on available data and propose a risk mitigation Interact with agencies in case of Paediatric Scientific Advice, presubmission meeting and all along the PIP procedure. Write the corresponding documents: briefing packages, slide decks, paediatric plans and corresponding synopses or justifications for waivers/deferral Coordinate on your behalf the full procedures (scientific advice/agency meeting, presubmission meeting, PIP/PSP) and can represent you at agency level in case of face-to-face meeting Our consultants will also assist you with any PIP amendments in your paediatric developments through the lifecycle of the product within the EU or US, the compliance check procedure or annual deferral report preparation and submission. BlueReg consultants have built a long experience these past years by supporting our clients in all key steps of the paediatric development. Our experts Our team can also support you through the entire application process from development, to registration and post-approval management Paula Buffery Séverine Waterdrinker Previous Associated services Drug Development Consulting & Strategy Currently developing a new medicinal product ? BlueReg can provide an end-to-end project plan to guide you from the development of your medicinal product right through to authorization and beyond. We can provide advice and recommendations to ensure the shortest time to market by minimising any possible barriers during the development process and beyond. Next Associated News FDA GUIDANCE – COVID-19 BlueReg continues to monitor the changes in the regulatory guidance and we wish to share... Learn more EMA GUIDANCE – COVID-19 Given the support given to our clients in interactions with health authorities all around the... Learn more eCTD Format Mandatory for EU National Procedures After CP, DCP/MRP Procedures, and according to the eSubmissions Roadmap Timelines, eCTD format is now... Learn more Contact our experts today Composed of proven experts from the pharmaceutical industry, our team is ready to answer to your needs in any area of product development, commercialisation and early access programs, and life cycle management Make an enquiry About us Welcome to BlueReg, an international consulting company for the pharmaceutical industry, specializing in development, regulatory affairs, economic affairs, quality and pharmacovigilance. We have built long-term partnerships with many clients by offering them “tailor-made” services guaranteeing expert advice and efficient solutions, thus supporting their projects towards success. 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