Federal Agency for Medecines and Health Products
Federal Agency for Medicines and Health Products(FAMHP)
FAMHP/initials/XX.XX.2008
Greet Musch , PhD 2.2.2009Director - General Pre authorisation
National network for clinical research in children
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Federal Agency for Medecines and Health Products
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1:Clinical trials in Belgium :organisation :
The Clinical trialTask Force is the Steering Committee assuring and surveilling the
adequate implementation of the law related to experiments on human beings.
( 7 May 2004 )
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1: Clinical trial Task Force
Different stakeholders represented :
• Core team:Representative of the Minister of Public Health Pharmaceutical IndustryEthics CommitteesCompetent Authority ( FAMHP )
• On ad hoc basis:Academic ResearchersPhase I units…
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1: Clinical trial Task Force
Strategic meetings on monthly basis :
Strategic Objectives :- Follow-up of activities of CA ( R&D
department ) and EC’s
- Fostering an optimal coöperation between CA and EC’s
- IT-strategy- Troubleshooting
Organisation of scientific/technical workshopsCommunication via websitewww.fagg.be
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Clinical Task Force
Steering Committee
Local EC’s
Representative of the minister
Stakeholders
Pharm. Ind. , Ac. Res. , ...
CA EC’s
(key representatives)
Technical Workshops
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Exchange of Scientific/Technical Info
(not-dossier related)Other EC’s
Clinical Trial Facilitation Group (HMA : FAMHP sponsor )
EC : Ad hoc working group
GCP : Inspectors meeting
EMEA ...
CA Key EC’s
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2. Global trends observed
- Number of patients involved in clinical trials : shift per region
279313
119215
9095822899
1212310961
4903
4647
4029
3346
832
0 100000 200000 300000
No PATIENTS
Re
gio
n
PATIENT INVOLVED IN CAP PRODUCTS PIVOTAL CTs FROM 2005 to 2007
Japan (0,30%)
Eastern Europe (1,22%)
Africa (1,47%)
Australia-New Zeland (1,70%)
CIS (1,79%)
Canada (4%)
Asia pacific (4,43%)
South-Central America (8,36%)
EU-Swiss (33,21%)
US (43,52%)
Total (100%)
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2. Global trends observed
87900
30036
28352
10226
9502
3473
2064
1656
1408
1183
0 20000 40000 60000 80000 100000
No Patients
Reg
ion
PATIENTS INVOLVED IN CAP PIVOTAL CTs IN 2007
CIS (1,35%)
Africa (1,60%)
Eastern Europe (1,88%)
Australia-New Zeland (2,35%)
Canada (3,95%)
South-Central America (10,81%)
Asia Pacific (11,63%)
US (32,25%)
EU-Swiss (34,17%)
Total (100%)
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3. Current situation in Belgium : 2005-2008
- 25 % Phase 1 trials from which 25 % FIH
0
100
200
300
400
500
600
Total files No phase I No phase II No exploratory
May 05 - 06
May 06 - 07
May 07 - 08
- Release of guidance document on exploratory trials : Mid 2007
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3. Current situation in Belgium : 2005-2008
Number of Phase I per million inhabitants
05
10152025303540
BE AU DK FR FN DE NL SP SW UK
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•Regulation 1901/2006 Art. 44
•Development of a EU paediatric network of existing national and EU networks , investigators and centres with specific expertise in the performance of studies in the paediatric population .
specific expertise , methodology , facilities appropriate trained investigators
•Objectives of the EU network Coordination of studies relating to medicinal products to avoid duplication of studies and testing in children
4: Paediatric clinical trials :national network :
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4: Paediatric clinical trials :national network :
•Benefits :
- build up complementary scientific and administrative competences at EU level ( avoid duplication )
- efficient use of facilities
- developing common methods of working
- QA : sharing best practices
Through efficient inter- network and stakeholder collaboration
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4: Paediatric clinical trials :national
network :
•Objectives of the network :
- Collaboration :
- cartography of and links with existing networks- ensure efficient communication between
networks ex-EU and WHO
- reference for health care professionals - scientific discussion with stakeholders
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4: Paediatric clinical trials :national
network : • Objectives of the network :
- Building competences :
- define scientific and operational quality standards and recognition criteria ( GCP )
- training and education program - stimulate development of new networks ,
centres , investigators
- stimulate research on trial methodology
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4: Paediatric clinical trials :national
network :
• Objectives of the network :
- Avoiding unnecessary studies :
- sharing information through the use of EudraCT
- develop multidisciplinary research partnership
- Stimulating high quality research :- increase awareness on the need of
clinical trials for children
- contribute to GCP compliance- ethical clinical research ( ex-EU )- stimulate research into off-patent
medicines- stimulate reserach in trial methodology
or non-invasive assays
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4: Paediatric clinical trials :national
network :
• Objectives of the network :
- Facilitation of implementation and recruitment of clinical trials :
- enable rapid attainment of sample sizes large enough to allow valid conclusions
- facilitate performance of trials through inter- networking also across member states
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Paediatric regulation
• April 2001: Directive 2001/20/EC: ‘Implementation of GCP in the conduct of clinical trials on medicinal products for human use’.
• July 2002: ‘Note for guidance on clinical investigation of medicinal products in the paediatric population’ (ICH Topic E11)
January 2007: Regulation (EC) N° 1901/2006
‘on Medicinal Products for Paediatric Use’
(and amendment 1902/2006)
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Paediatric regulation: objectives
To improve the health of children in Europe by: facilitating the development and availability of
medicines for children aged 0 to 17 years, and over time, ensuring that the majority of medicines used by children are specifically authorized for such use,
ensuring that medicines for use in children are of high quality, ethically researched, and authorised appropriately,
improving the availability of high quality information on the use of medicines for children,
Without:
subjecting children to unnecessary trials,
or delaying the authorisation of medicines for use
in adults.
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Paediatric regulation
Three domains of activity:
Paediatric drug development (PIPs)
*Promotion of paediatric clinical research*
Information
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Next steps: definition of a network
”A network is a virtual structure defined by a formal agreement between individuals, organisations or structures sharing and collaborating towards the same objectives, goals and quality standards”
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Cardiovascular Diseases
Dermatology
Endocrinology-Gynaecology-Fertility-MetabolismGastroenterology-Hepatology
Haematology-Hemostaseology
Immunology–Rheumatology-TransplantationInfectious Diseases
Neonatology - PaediatricIntensive CareNeurology
Oncology
Ophthalmology
Other
Oto-rhino-laryngology
Pain
Pneumology – Allergology
Psychiatry
Uro-nephrology
Vaccines
Therapeutic areas of interest (PIPs)
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5: Role of the FAMHP:
-Active facilitator in sharing scientific knowledge with the different stakeholders ( ethics committees inclusive )
- Active facilitator in stimulating GCP practices and sharing best practices within and between academic centres
-Active facilitator in establishing interfaces with EU networks
Meeting with representatives of the Minister scheduled : March 2009 EMEA workshop : 16 th February
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Thank you for your attention Dr. Greet Musch, Head of Department R&D
Victor Horta Place 40/40, 8th Floor 1000 Brussels
[email protected]+ 32 2 524 80 65
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