Teddy Netw ork of Excellence Teddy Netw ork of Excellence Funded under the Com m unity Funded under the Com m unity’ ’s Sixth Fram ew ork Program m e s Sixth Fram ew ork Program m e FI RST EMEA W ORKSHOP ON EUROPEAN FI RST EMEA W ORKSHOP ON EUROPEAN PAEDI ATRI C NETW ORK PAEDI ATRI C NETW ORK EMEA, Conference Conference Room 2 Room 2° ° EMEA, 16 February February 2009 2009 16 TEDDY Netw orking Experience (in the Paediatric Medicines Research Sector) ADRI ANA CECI , TEDDY NoE Coordinator TEDDY TEDDY T ask-force in E urope for D rug D evelopment for the Y oung 16 February 2009, 9.00-16.30 7, Westferry Circus, Canary Wharf, London E14 4HB
Teddy Network of Excellence Teddy Network of Excellence Funded under the Comm unity Funded under the Comm unity’ ’s Sixth Framework Programme s Sixth Framework Programme TEDDY is a Netw ork of Excellence funded under the 6° Framework Program, encompassing 19 Research Centers and 10 European Countries and Israel and is cooperating with more than 200 researchers and experts Aimed at increasing availability of paediatric safe and efficacious drugs TEDDY T T ask force in E E urope for urope for D D rugs rugs D D evelopment for the Y Y oung ask- -force in evelopment for the oung
W HAT’ ’S S TEDDY? TEDDY? W HAT TEDDY I S A NETW ORK: A NEW RESEARCH I NSTRUMENT to straightening paediatric research and supporting both TEDDY Research groups and the existing external Networks, Societies and Experts to perform common and innovative initiatives including those that would be more difficult to execute in lack of a supportive action . Networking is the core of the mission of TEDDY TEDDY T T ask force in E E urope for urope for D D rugs rugs D D evelopment for the Y Y oung ask- -force in evelopment for the oung
How is TEDDY fulfilling its How is TEDDY fulfilling its obligations? obligations? TEDDY NoE STRUCTURE Networking has been one of the more relevant activities of TEDDY and has also facilitated the achievement of its main project results as surveys, data banking, innovative methodologies identifications, inventories of researchers and research, and so on. Scientific Results 11 PR publications, 1 Monograph 3 Methodological testbooks, 1 Website , 3-monthly news-letters TEDDY T ask T force in E E urope for urope for D D rugs rugs D D evelopment for the Y Y oung ask- -force in evelopment for the oung
ACTIVITIES AND PRINCIPAL RESULTS Surveys, data collection and bibliographic searches have been used to picture the current situation as well as to identify research priorities Common expertises, material and human resources have been exchanged and shared to plan Paediatric innovative research and methodologies Disseminate and provide opinion on key documents and institutional rules and guidelines with reference to paediatric needs, methodological aspects, ethic, comunication, etc TEDDY T ask T force in E E urope for urope for D D rugs rugs D D evelopment for the Y Y oung ask- -force in evelopment for the oung
TEDDY Netw orking Methodology Netw orking Methodology TEDDY • Contact and interconnect ‘ noncompeting ’ people having similar interest or concerns – Search for sector of interest and know ledge • Create consensus on content and instruments to be used for common research – Surveys- Focus Groups-Questionaires • To circulate knowledge and skills along the ‘ points ’ and the ‘ nodes ’ of the Network – Personel ecxhange,-e-learning courses , m eeting participation, ecc • Favour relationship among interested parties – Open Conferences-W orking Groups TEDDY T T ask force in E E urope for urope for D D rugs rugs D D evelopment for the Y Y oung ask- -force in evelopment for the oung
N EDDY Netw orking EDDY Netw orking N quality standards and recognition criteria quality standards and recognition criteria Non-competitiveness among participants Exixting Paediatric Interest on the project Networks Existing Good comunication Paediatric skills and Scientific opportunities . Societies To be in contact with the Paediatric Community (scientific, authorities, professionals, companies, associations,ecc) Regulatory Bodies w ith Paediatric vocation To deserve time and appropriate resources TEDDY T ask T force in E E urope for urope for D D rugs rugs D D evelopment for the Y Y oung ask- -force in evelopment for the oung
TEDDY Experts Groups TEDDY Experts Groups quality standards and recognition criteria quality standards and recognition criteria -2- Experts should be TD- RCM.001-September expected to act in an 2005 independent manner Expert Groups Start- Up Reference Guide -3- A diversity of view TD-W P0 4 .0 0 1 - Novem ber points should be 2 0 0 5 assembled. GUI DELI NES ON SETTI NG . UP THERAPEUTI C individuals outside partners’ s EXPERTS GROUPS: habitual circle of contacts STANDARD should be included OPERATI NG PROCEDURES ( SOP) -1- The quality of scientific expertise can be based on the excellence of scientists. TD-W P0 4 .0 0 2 - Decem ber 2 0 0 5 THERAPEUTI C (number and impact of refereed publications) GROUPS ACTI VI TI ES However, it may also include practical knowledge . TEDDY T T ask force in E E urope for urope for D D rugs rugs D D evelopment for the Y Y oung ask- -force in evelopment for the oung Source: Principles on the collection and use of expertise ( EC 2 0 0 2 ) 0 2 ) Source: Principles on the collection and use of expertise ( EC 2 0
Succesful Netw orking activities Succesful Netw orking activities Collaborating Poeple oeple Collaborating P Academy & Researcher • 410 • 210 Public Health Other Professional • 48 Industries • 94 Associations • 30 European Countries: 2 5 European Countries : 2 5 No European Countries No European Countries: 8 : 8 TEDDY T T ask force in E E urope for urope for D D rugs rugs D D evelopment for the Y Y oung ask- -force in evelopment for the oung
Succesful Netw orking activities : Succesful Netw orking activities : Collaboration and and partnerships w ith other partnerships w ith other Collaboration netw orks/ / groups groups netw orks ENDI iC EMEA EMEA ECRI N E.C. PEDI ANET ENDI iC ECRI N E.C. PEDI ANET ENCePP ENCePP Teddy Teddy P.MECHI LD P.MECHI LD RESPECT RESPECT EFGCP National EPA EPA PENTA Printo EFGCP National PENTA Printo Netw orks Specialised N. N. Netw orks Specialised TEDDY T ask T force in E E urope for urope for D D rugs rugs D D evelopment for the Y Y oung ask- -force in evelopment for the oung
Succesful Netw orking activities Succesful Netw orking activities Defining off- - label and unlicensed use of m edicines label and unlicensed use of m edicines Defining off . for children: results of a Delphi survey . for children: results of a Delphi survey Table 1 : Com position of the Expert Panel The aim of this Delphi survey is to develop Invited participants % (n) % (n) common definitions for unlicensed and off-label drug use in children to be used for research and regulatory purposes. Health Professionals 14.29 (12) 20.59 (7) After a literature review on the current Industry 8.33 (7) 8.82 (3) status of unlicensed/ off-label definitions, a Regulatory 20.24 (17) 14.71 (5) two-stage, web-based Delphi survey was conducted among experts in Europe. Scientists 52.38 (44) 55.88 (19) Results were then consulted with the Other 4 0 European Medicines Agency (EMEA) Total 84 34 The lowest level of consensus reached was for questions related to a different formulation or if a drug was given although contraindicated. At the final step, 85% of the responding experts agreed on the proposed definition for off- label (use of a drug already covered by a Marketing Authorisation, in an unapproved way) and 80% on the definition for unlicensed. TEDDY T T ask force in E E urope for urope for D D rugs rugs D D evelopment for the Y Y oung ask- -force in evelopment for the oung Pharmacol Res. 2008 Nov-Dec;58(5-6):316-22. Epub 2008 Sep 18
Succesful Netw orking activities Succesful Netw orking activities Networking & Unmet Therapeutic Needs The Paediatric Committee shall One of the TEDDY key establish an inventory of objective has been to therapeutic needs , with a contribute to identify view to identifying research unmet therapeutic needs priorities . The Agency shall make the inventory public at the latest by 26 January 2010 • assessing and profiling the current paediatric (Paed. Reg. art. 43) medicines uses • identifying research priorities to meet therapeutic needs This has been done by Setting up Therapeutic Experts Groups (TEGs) TEDDY T T ask force in E E urope for urope for D D rugs rugs D D evelopment for the Y Y oung ask- -force in evelopment for the oung
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