title: The Task-force in Europe for Drug Development for the Young (TEDDY) Network of Excellence.
abstract: The Task-force in Europe for Drug Development for the Young (TEDDY) was established in 2005 to contribute to the promotion of safe and efficacious medicines for children in the context of the impending European Paediatric Regulation that finally came into force in January 2007. The project includes seven objectives and 12 Work-Packages encompassing the main aspects of the development and use of pediatric drugs. TEDDY represents a new entity in the pediatric pharmaceutical field, differing from a Scientific Society, a network for developing research or trials, or a consultative regulatory body. The ambition of TEDDY is to support the existing pediatric networks, societies, and regulatory bodies in performing innovative initiatives, including those in areas in which such undertakings would not be feasible without supportive action. To accomplish its aim, TEDDY has focused on three different actions: (i) increasing awareness about the Paediatric Regulation revolution; (ii) reaching consensus on terms and instruments to be used for common research; and (iii) favoring close relationships among different stakeholders and partners from different EU Member States. After 3 years of activities, many results have been produced by the Network: surveys, databases, expert opinions, and recommendations. Linking together different stakeholders, including industry and patient associations, as well as academia and research centers, the Network has contributed to increasing awareness and participation in the Paediatric Regulation. In addition, many papers detailing original results have either been published or submitted for publication in peer-reviewed journals. TEDDY is an original Network whose identity and role as a catalyzer of initiatives related to the use and development of pediatric drugs needs to be better clarified in the near future. Of particular importance is the need to reach consensus on best practices. The lack of a common view on pediatric research requirements among stakeholders across Member States remains the main challenge to be overcome.
authors.affiliation: Consorzio per Valutazioni Biologiche e Farmacologiche, Pavia, Italy. adriana.ceci@teddynoe.org
authors.forename: Adriana
authors.initials: A
authors.lastname: Ceci
authors.forename: Carlo
authors.initials: C
authors.lastname: Giaquinto
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Aboulker
authors.forename: Paola
authors.initials: P
authors.lastname: Baiardi
authors.forename: Fedele
authors.initials: F
authors.lastname: Bonifazi
authors.forename: Oscar
authors.initials: O
authors.lastname: Della Pasqua
authors.forename: Alfredo
authors.initials: A
authors.lastname: Nicolosi
authors.forename: Domenica
authors.initials: D
authors.lastname: Taruscio
authors.forename: Miriam
authors.initials: M
authors.lastname: Sturkenboom
authors.forename: Ian
authors.initials: I
authors.lastname: Wong
mesh_terms: D000293:Adolescent; D026683:Advisory Committees / Q000458:organization & administration*; D002648:Child; D002675:Child, Preschool; D016208:Databases, Factual; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004358:Drug Therapy / Q000706:statistics & numerical data*; D005060:Europe; D006077:Government Agencies; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D010372:Pediatrics