TEDDY is an independent multidisciplinary and multinational Network where researchers, scientists and health experts work together to identify the most appropriate common rules that reflect the specificity of the patient population.
Here is the list of TEDDY Network expertise/services, together with reference contacts. The following activities are intended to cover different therapeutic areas in paediatric, with particular reference to the following ones, for which several consolidated previous experiences have been conducted: haematology, oncology, infectious diseases, respiratory diseases, intensive care, pain, endocrinology, rare diseases and neonatology.
| Topic | Description | Reference contact(s) |
|---|---|---|
| Medicines formulation | Design and development of new paediatric drug formulations | Nunzio Denora - nunzio.denora@uniba.it Lidwien M. Hanff Dutch Knowledge Center Pharmacotherapy Children - info@nkfk.nl Anna Cantarutti - a.cantarutti@campus.unimib.it |
| Planning and design of clinical trials | Methodological aspects of clinical research, with reference to innovative and traditional studies design, including population PK study, Modeling&Simulation, extrapolation | Florentia Kaguelidou (methodology) - florentia.kaguelidou@aphp.fr Elsa Maksoud (popPK and simulations) - elsa.maksoud@aphp.fr Alberto M. Borobia - a.borobia@gmail.com Antonio J. Carcas - Antonio.carcas@uam.es Dutch Knowledge Center Pharmacotherapy Children - info@nkfk.nl Oscar Della Pasqua - o.dellapasqua@ucl.ac.uk Rebecca Lundin - Rebecca.lundin@pentafoundation.org Paola Baiardi - paola.baiardi@fsm.it Adriana Ceci - adriceci.uni@gmail.com Anna Cantarutti - a.cantarutti@campus.unimib.it |
| Non-interventional studies | Planning and conduction of observational studies, post-marketing studies and long-term studies | Florentia Kaguelidou - florentia.kaguelidou@aphp.fr Hoi Y. Tong - Hoi.tong@idipaz.es Manika Kreka manikaface@yahoo.com Eleni Nastas - eleninastas@yahoo.com Rebecca Lundin - Rebecca.lundin@pentafoundation.org Fedele Bonifazi - fb@benzifoundation.org Mariagrazia Felisi - mfelisi@cvbf.net Lucia Ruggieri - l.ruggieri@gisf.info Antje Neubert - antje.neubert@uk-erlangen.de Anna Cantarutti - a.cantarutti@campus.unimib.it |
| Regulatory | Preparation of regulatory applications for European Medicines Agency (e.g. orphan designation, Paediatric Investigation Plans) | Valery Elie - Valery.elie@aphp.fr Evelyne Jacqz-Aigrain - evelyne.jacqzaigrain@aphp.fr María Posada - Maria.posada@idipaz.es Oscar Della Pasqua - o.dellapasqua@ucl.ac.uk Laura Mangiarini - Laura.mangiarini@pentafoundation.org Antje Neubert - antje.neubert@uk-erlangen.de Adriana Ceci - adriceci.uni@gmail.com Lucia Ruggieri - l.ruggieri@gisf.info Cristina Manfredi - cmanfredi@cvbf.net Cecilia Allievi - callievi@cvbf.net Carlo Giaquinto - Carlo.giaquinto@unipd.it |
| Ethics and Clinical Trial Applications | Preparing and submission of ethical, scientific and legal documentation to the Ethics Committees and European/ National Authorities. Third countries are included. | Viviana Giannuzzi - vg@benzifoundation.org Alicia Herranz - Herranz.estelles@gmail.com Laura Mangiarini - Laura.mangiarini@pentafoundation.org Irmgard Toni - irmgard.toni@uk-erlangen.de Annagrazia Altavilla - annagrazia.altavilla@univ-amu.fr Luigina Tagliavacca - luiginatagliavacca@pharmsrl.com Donato Bonifazi - donatobonifazi@pharmsrl.com Cecilia Allievi - callievi@cvbf.net Carlo Giaquinto - Carlo.giaquinto@unipd.it |
| Pharmacovigilance | Conduction of pharmacovigilance activities from SAEs handling to DSUR preparation and submission. | Cristina Manfredi - cmanfredi@cvbf.net Mariagrazia Felisi - mariagraziafelisi@ pharmsrl.com Hoi Y. Tong - Hoi.tong@idipaz.es Ilda Mallkuci - Ildushka81@live.it Irmgard Toni - irmgard.toni@uk-erlangen.de Carlo Giaquinto - Carlo.giaquinto@unipd.it |
| Clinical trial conduction | SOPs on biostatistics, data management, drug management, monitoring, quality assurance and clinical trial management procedures. Strategies for clinical trials conduction and patients recruitment optimisation | Florentia Kaguelidou - florentia.kaguelidou@aphp.fr Evelyne Jacqz-Aigrain - evelyne.jacqzaigrain@aphp.fr Donato Bonifazi - ceo@cvbf.net Mariagrazia Felisi - mariagraziafelisi@pharmsrl.com Hoi Y. Tong - Hoi.tong@idipaz.es Manika Kreka - mkreka@cvbf.net Anila Godo - godoanila@gmail.com Oscar Della Pasqua - o.dellapasqua@ucl.ac.uk Carlo Giaquinto - carlo.giaquinto@unipd.it Paediatric Clinical Study Centre University Hospital Erlangen, Germany - paed-studienzentrale@uk-erlangen.de Carlo Giaquinto - Carlo.giaquinto@unipd.it |
| Communication and education | Development of educational and informative tools to improve knowledge on the topics of paediatric research to laymen people and promote the empowerment of paediatric patients involved in clinical trials | Evelyne Jacqz-Aigrain - evelyne.jacqzaigrain@aphp.fr Maria Cavallo - mcavallo@puglialav.com Mariangela Lupo - mlupo@cvbf.net Donato Bonifazi - db@benzifoundation.org Jesús Frías - Jesus.frias@uam.es |