European Paediatric Formulation Initiative (EuPFI) is a consortium working in a pre-competitive way on paediatric drug formulations. Members are from academia, hospital pharmacies, pharmaceutical industry (Innovators, Generics,Contract Research Organizations (CRO), Specials and Excipient Manufacturers) with European Medicine Agency (EMA) as an observer. It aims to expedite the development of better and safer medicines for children by identifying and scoping issues and challenges in paediatric formulation development. It brings together the voluntary, academic, pharmaceutical industry, hospitals and regulatory agency in order to tackle the development of age appropriate formulation for paediatrics. It provides funding, expertise and resources to support the solutions to the problems and new technologies emerging from academic research.
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The International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) is a technically-focused organization of pharmaceutical and biotechnology companies with a mission of advancing science-based and scientifically-driven standards and regulations for pharmaceutical and biotechnology products worldwide. In January 2014 IQ joined the European Pediatric Formulation Initiative (EuPFI) to further efforts to promote global alignment on pediatric product development. EuPFI is a consortium that has been instrumental in driving science and science-based standardization for pediatric formulation development. Membership in EuPFI allows IQ and EuPFI to join forces in addressing a topic with public health significance.
Excipients are used to facilitate the manufacturing of dosage forms and maintain the stability of medicines in the face of chemical and microbial challenges. The lack of neonatal safety information exposes these patients to the risk of specific adverse reactions unexpected from adult experience.
The ESNEE project, "Strategy for the extensive review of the literature on excipient toxicities" aimed to develop and validate a systematic and standardised search strategy for collecting relevant information about excipients.
EuPFI in collaboration with its network of partners secured a £660,000 grant from the Technology Strategy Board, the UK’s innovation agency, towards a £1 million project aimed at accelerating paediatric formulation development through smart design and predictive science.
The consortium aimed to address the need for improved speed, cost and quality of paediatric formulation by drawing on the combined expertise of its members. The goal was to deliver a novel, commercially available, regulatory-approved platform to identify the most appropriate delivery strategy for paediatric medicines.