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HUNGARIAN PRIMARY CARE PEDIATRICIANS’ CLINICAL RESEARCH NETWORK EDINA STUNYA MD CHAIRWOMAN 7-8 TH JUNY 2018, LONDON, ENPREMA MEETING .
HUNGARIAN PRIMARY CARE PEDIATRICIANS’ CLINICAL RESEARCH
NETWORK
EDINA STUNYA MD CHAIRWOMAN
7-8 TH JUNY 2018, LONDON, ENPREMA MEETING
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POPULATION IN HUNGARY IN 2018: 9 771 000
0-14 YEARS OF AGE: 1 421 000 15-19 YEARS OF AGE : ABOUT 400 000
CARED BY PRIMARY CARE PAEDIATRICIANS
70% OF CHILDREN BELOW 14 YEARS OF AGE 60 % OF CHILDREN BETWEEN 14-18 YEARS OF AGE
1,2 MILLION CHILDREN
HUNGARIAN PRIMARY CARE PAEDIATRICIAN ASSOCIATION (HGYE)
HunPedNet : is an organization with independent legal entity within the framework of Hungarian
Primary Care Paediatrician Association
Financial support from MCRN Hungary
MISSION AND AIMS OF HUNPEDNET • HunPedNet was created with the aim of obtaining new
medicines, formulas and vaccines for Hungarian children via facilitating conducting clinical trials in children.
• Clinical trials are conducted according to GCP and comply with EU Directive 2001/20/EC on Clinical Trials.
• The Hungarian and European data protection regulation is adhered.
• We keep ethical considerations for clinical trials on medicinal products conducted with the paediatric population.
• Clinical trials can be conducted based on approval of independent ethics committee with paediatric expertise.
• We collaborate with patient organisations, with paediatric clinical research networks, with CROs.
EVERYDAY ACTIVITY OF HUNPEDNET
• Feasibilty dissemination among HunPedNet members, collecting the colleagues interested in and mediate between the CRO/sponsor and
the prospetive investigators
• Organize on job training
• Newsletters about GCP trainings and conferences
• We do not facilitate contracting at the moment
• Later we may centralize the:
• Contracting
• Source documentation template
• SOP writing
• Instrument purchase and calibration
HUNPEDNET: 94 MEMBERS IN HUNGARY
THE POPULATION IN PRAXISES OF MEMBERS more than 80 THOUSAND CHILDREN BETWEEN 0-19 YEARS OF AGE
500 fő: 1 praxis
500-600 fő: 6 praxis 600-700 fő:
4 praxis
700-800 fő: 6 praxis
800-1000 fő: 36 praxis
1000 fő fölött: 35 praxis
HUNPEDNET MEMBERS HAVE 20 KIND OF SPECIALITIES
BEYOND PAEDIATRICS • pulmonology
• intensive therapy
• neonatology
• immunology
• allergology
• cardiology
• radiology
• school doctor
• specialist of infectious diseases
• dermatology
• clinical pharmacology • psychotherapy / mental
health hygiene • lipidology license • diabetology license • rehabilitation • CRA • nephrology • haematology • gastroenterology • sports medicine
RELATIONSHIP OF HUNPEDNET
MCRN Hungary
HGYE Paediatric Association
MKVT Clinical Trial Management Society Hungary
Patient Organizations in Hungary: •Alliance of Patient Organizations in Hungary
•National Association of Rare and Congenital Disorders
EnprEMA
Hungarian ECRIN
WHAT ABOUT MCRN HUNGARY, HUNPEDNET AND THE FUTURENEST LTD. RELATIONSHIP?
• Primary care peadiatricians work separately from hospitals
• The relationship is good enough with physicians working in hospitals, but not always conflict-free
• Primary care peadiatricians have independent above mentioned association (HGYE) and are contacted /addressed and organized to do some new good things such as HunPedNet only via this association, in the frame of their own association. HunPedNet is not a for profit organization.
• MCRN Hungary aims to collect all paeditaricians conducting clinical trials in Hungary not only those working in primary care, and it also supported financially the organizing of the HunPedNet.
• Futurenest Ltd – earlier known in EnprEma as a paediatric primary care network, has some own sites in Hungary. It is a for profit Ltd which condudts paediatric clinical trials from 2010 and has investigators with great experience. The owners of Futurenest Ltd (who are members of the Primary Care paeiatricians Association as well) recognized at the meetings in EMA that it is very important to establish a network for the whole country to attract more peadiatric clinical trials for Hungarian children. MCRN Hungary and HunPedNet were organized parallel at the same time.
THANK YOU FOR YOUR ATTENTION!
www.hunped.net
In developing
