 Regulatory
and Ethics
Ethics Committees are either established at hospitals,
the Chamber of Physicians or at the district government.
One of the LECs is to be selected as "lead" EC providing
a "single vote" for Slovakia; the others act as local
ECs in charge of the trial site exclusively. The period for
granting an EC's opinion is limited to 60 days. Additional and not
in accordance with the EU CT Directive private sites have to be
approved by the district government (samospravny kraj), after
having obtained the national CA's and national EC's approval. The
procedure may prolong the authorisation period beyond the 60-day
timeline .
The parallel process of clinical trial authorisation by the competent
Slovak authorities takes 60 days for phases I to IV; EMEA's request form is to be
used.
Any objections or requests for completion may prolong the authorisation
process. The extent of documentation to be submitted, esp.
pharmaceutical data (IMP dossier)
depends on the trial drug's registration status in the EU and complies
with the requests of the EU
Directive.
Since 2006 the applicant needn't to be a Slovak (natural or legal)
person any more.
Standard patient insurance fully acknowledged but insurance must have a national representative, insurance
for investigators and sponsor required.
Customs clearance for IMPs of EU origin is not requested.
Overall approval time for both in parallel, EC and CA, is about 60 days.
Depending on specialisation, the degree of privatisation ranges from
20% to 80% and a major part of outpatients could still be found centrally
in hospitals.
Infrastructure
Communication facilities comparable to Western Europe.
Small country, highway access to major towns, highway to Czech Republic.
No fast inter-city train system available. From Bratislava few direct
flights to European capitals.
Vienna (int’l airport) about 1,5 hour by car/ shuttle bus.
Local PHAMOS office
Business in Slovakia is run by the CEE headquarters in Prague
and by the national study co-ordinator based in Bratislava. Slovak
and Czech languages are almost identical so that communication with
investigators, authorities, EC's and hospital depts. is easily
possible for the Prague staff.
PHAMOS s.r.o., Na Porici 30, CR- 110 00 Prague 1, Czech Republic
Phone +420. 2173. 2085 Fax +420. 2173. 2185
Email praha@phamos.cz
Clinical trial authorisation and EC opinion, feasibility
survey, site
selection and set-up, on-site monitoring, national project
management
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