1:clinical trials in belgium :organisation :

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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FAMHP/initialsXX.XX.2008


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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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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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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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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

1:clinical trials in belgium :organisation :

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