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1.10.03 - gvdCT Monitoring1 Swiss Agency for Therapeutic Products.

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Presentation on theme: "1.10.03 - gvdCT Monitoring1 Swiss Agency for Therapeutic Products."— Presentation transcript:

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2 gvdCT Monitoring1 Swiss Agency for Therapeutic Products

3 gvdCT Monitoring2 Study Notification Activity ( ) Review of the Clinical Trials activity in Switzerland G. Vital-Durand

4 gvdCT Monitoring3 Role of Swissmedic [ 1 ] Swiss Federal Regulatory Agency Established 2002 [ ]

5 gvdCT Monitoring4 Role of Swissmedic [ 2 ] NDA Reviews Marketing Authorisations Pharmacopoeia Monographies Pharmacovigilance [ Benini F. Bittere Medizin für Heilmittelinstitut. NZZ 2003 : 20th July ]

6 gvdCT Monitoring5 Role of Swissmedic [ 3 ]

7 gvdCT Monitoring6 Role of GCP Unit CT Notification and Follow-up Safety Data Collection GCP Monitoring [ Anonymous. Reglement über die Heilmittel im klinischen Versuch. Ergänzende Erläuterungen. Monatsbericht der IKS 2000 ; 3 : ]

8 gvdCT Monitoring7 CT Flow Rate ( )

9 gvdCT Monitoring8 CT Categorisation ( )

10 gvdCT Monitoring9 Development Phases ( )

11 gvdCT Monitoring10 Therapeutic Areas ( )

12 gvdCT Monitoring11 Conclusions [ 1 ] Clinical Research is intensive, albeit on a slightly declining trend (to be reversed in 2003 ?) Most CT components have remained stable over time, e.g. flow, clinical phase distribution, multi- vs. monocentre type, distribution of therapeutic areas

13 gvdCT Monitoring12 Conclusions [ 2 ] The major 6 medical indications accounted for ca. one half (43-60 %) of the total CT activity, with minimal variations from year to year Phase-I CTs have been mostly conducted by CROs located in BL and TI, on assignment by foreign companies

14 gvdCT Monitoring13 Swiss Agency for Therapeutic Products


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