TEDDY Leaflet - TEDDY Network

TEDDY is an independent multidisciplinary and multinational
Network including partners from 18 countries and is aimed at
facilitating the performance of good quality paediatric studies and
research. TEDDY is a member of Enpr-EMA, the European Network
of Paediatric Research at the European Medicines Agency.
MISSION
To implement good practices and tools to develop studies and research
on medicinal products in children in compliance with EU legislation and
guidelines
To promote, participate in and provide methodological expertise to set
up, develop and conduct paediatric national or multinational clinical
trials and other paediatric studies
To collaborate with existing paediatric networks and research organisations
To develop communication and educational tools tailored for children
in order to facilitate their participation in all the relevant experimental
procedures including assent and consent forms preparation
TEDDY NETWORK is coordinated by
Consorzio per Valutazioni Biologiche e Farmacologiche
Via Luigi Porta 14 - 27100 Pavia (Italy) - Tel.: +39 0382 25075
Via Nicolò Putignani 178 - 70122 Bari (Italy) Tel.: +39 080 86 41 260
TEDDY MEMBERS:
Consorzio per Valutazioni Biologiche e
Farmacologiche, Italy
Assistance Publique - Hopitaux de Paris,
France
Azienda Ospedaliera Antonio Cardarelli, Italy
Azienda Ospedaliera di Padova, Italy
Azienda Ospedaliera Ospedali Riuniti Villa
Sofia-Cervello, Italy
Azienda Ospedaliero Universitaria
Consorziale Policlinico di Bari, Italy
Azienda Ospedaliero-Universitaria di
Modena, Italy
Barts Health NHS Trust, United Kingdom
Cairo University, Egypt
Centre National de Greffe de Moelle
Osseuse, Tunisia
Charité - Universitätsmedizin Berlin,
Germany
Childhood Cancer International, The
Netherlands
Consorzio per Valutazioni Biologiche
e Farmacologiche - Branch of Albania,
Albania
Erasmus Universitair Medisch Centrum
Rotterdam, The Netherlands
Erasmus MC Sophia Children’s Hospital,
The Netherlands
Espace Ethique Méditerranéen CHU
Marseille (AP-HM / AIX-MARSEILLE
UNIVERSITÉ), France
Fondazione PENTA Onlus, Italy
Fondazione per la Ricerca Farmacologica
“Gianni Benzi” Onlus, Italy
Geniko Nosokomeio Paidon Athinon I Agia
Sophia - Paidon Pentelis, Greece
Gothia Forum for Clinical Research, Sweden
Gruppo Italiano per gli Studi di
Farmacoeconomia, Italy
Hospital Sant Joan de Déu, Spain
Hospital Universitario La Paz, Spain
Hospital Universitario 12 de Octubre, Spain
Inserm SC10, France
Institute of Physiology ASCR, v.v.i., Czech
Republic
Instytut Pomnik Centrum Zdrowia
Dziecka, Poland
Istituto Superiore di Sanità, Italy
Medical and Public Health Services of the
Cyprus Ministry of Health, Cyprus
National and Kapodistrian University of
Athens, “AGIA SOPHIA” Children’s Hospital,
Greece
Ospedale Pediatrico Bambino Gesù, Italy
PHARM – PHArmaceutical Research
Management Srl, Italy
Phoenix Clinical Research, Lebanon
Romanian Angel Appeal Foundation,
Romania
Società Servizi Telematici Srl, Italy
Technion - Israel Institute of Technology,
Israel
Università degli Studi di Napoli Federico
II, Italy
Università degli Studi “Gabriele
D’annunzio” Chieti - Pescara, Italy
Universitätsklinikum Erlangen, Germany
University College London, United Kingdom
University Hospital Center “Mother
Teresa”, Albania
University of Edinburgh, United Kingdom
University of Hong Kong, China
University of Liverpool, United Kingdom
ACTIVITIES
PROJECTS
TEDDY started as a FP6 funded project and promoted, together with its members, several FP7
projects including research-driven paediatric clinical trials: CloSed, DEEP, GAPP, NeoMero, NeoVanc.
In the new Horizon 2020 framework, SMART - Small Medicines Advanced Research Training, a
Twinning project started in 2016, is gathering 4 TEDDY members, and PedCRIN - Paediatric Clinical
Research Infrastructure Network, an Infradev3 project coordinated by ECRIN and involving CVBFTEDDY as a partner, will soon be kicked off.
INFORMATIVE TOOLS
TEDDY is now performing an online survey to collect general information on investigational
centres in EU and non-EU countries participating in paediatric research. Results will be made
available to EnprEMA (the European Network for Paediatric Research at the EMA) and will be
used in the implementation phase of EPCT-RI, the proposed European Paediatric Clinical Trials Research Infrastructure.
A database, the European Paediatric Medicines Database (EPMD), containing information on
paediatric drugs authorised by the European Medicines Agency (EMA) under the centralised
procedure, has been created and is available online.
An Inventory of the Ethical and Regulatory procedures for paediatric clinical trial (CT) approval
and conduction in EU and non-EU countries has been performed. It includes information on
the relevant local and national requirements and procedures to apply Ethics Committees and
concerned Authorities’ authorisation and to submit periodic information to the same Bodies. The
inventory is going to be implemented with pharmacovigilance requirements.
PRODUCTS
Study Specific Procedures for paediatric clinical trials.
Videos and age-appropriate informative material to duly inform children and families.
E-learning courses to train Investigators and patients for an effective participation in clinical trials.
Join the TEDDY NETWORK!
For more information please contact
the Network Coordinator at
[email protected]
or visit our website
w w w. t e d d y n e t w o r k . n e t