1:Clinical trials in Belgium :organisation :

1. 1

2. 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 ) 1:Clinical trials in Belgium :organisation : 2

3. Different stakeholders represented : Core team: Representative of the Minister of Public Health Pharmaceutical Industry Ethics Committees Competent Authority ( FAMHP ) On ad hoc basis: Academic Researchers Phase I units … 1: Clinical trial Task Force 3

4. 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 workshops Communication via website www.fagg.be 1: Clinical trial Task Force 4

5. Representative of the minister Clinical Task Force Steering Committee Stakeholders Pharm. Ind. , Ac. Res. , ... CA EC’s (key representatives) Local EC’s Technical Workshops 5

6. Exchange of Scientific/Technical Info(not-dossier related) CAKey EC’s Other EC’s Clinical Trial Facilitation Group (HMA : FAMHP sponsor ) EC : Ad hoc working group GCP : Inspectors meeting EMEA ... 6

7. 2. Global trends observed • Number of patients involved in clinical trials : • shift per region 7

8. 2. Global trends observed 8

9. 3. Current situation in Belgium : 2005-2008 • - 25 % Phase 1 trials from which 25 % FIH - Release of guidance document on exploratory trials : Mid 2007 9

10. 3. Current situation in Belgium : 2005-2008 10

11. 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 : 11

12. 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 4: Paediatric clinical trials :national network : 12

13. 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 4: Paediatric clinical trials :national network : 13

14. 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 4: Paediatric clinical trials :national network : 14

15. 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 15

16. 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 4: Paediatric clinical trials :national network : 16

17. 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) 17

18. 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 authorisedappropriately, • 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. 18

19. Paediatric regulation • Three domains of activity: • Paediatric drug development (PIPs) • *Promotion of paediatric clinical research* • Information 19

20. 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” 20

21. Therapeutic areas of interest (PIPs) 21

22. 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 5: Role of the FAMHP: 22

23. Thank you for your attention Dr. Greet Musch, Head of Department R&D Victor Horta Place 40/40, 8th Floor 1000 Brussels Greet.Musch@fagg.be + 32 2 524 80 65 23