APPROVALS

Irish law allows for the conduct of experimental studies within the final two years of the patent life of a reference product.

Irish Medicines Board

The Clinical Trials Act of 1987 requires that an application be made to the Irish Medicines Board [IMB] in order to seek permission to conduct a clinical trial. Submission deadlines for applications occur monthly. Shandon Clinic has an excellent relationship with the IMB, having worked closely with this body for more than 10 years. We have the necessary expertise to ensure rapid submission and approval of clinical trial applications. Provided that the client supplies the limited pharmaceutical data required, permission to proceed with a clinical study is generally obtained within 28 days of submission.

It is also possible to make a generic application for a series of pilot studies (involving multiple similar formulations). Once such an application is approved, each new pilot formulation is subject to an expedited review, and is cleared for administration within 5 to 10 days of IMB notification.

The European Clinical Trials Directive ensures standards that have already been in effect in Ireland since the publication of the Clinical Trials Act. Accordingly, we expect no interference with the present system when the Directive is enforced throughout Europe in 2004. Customers of UK based CRO's, by contrast, may experience delays in obtaining MHRA approval for trials as the UK struggles to come to terms with the new legislation.


Ethics Committee

Shandon Clinic submits all study protocols to the Research Ethics Committee of the Cork Teaching Hospitals, an independent, university-based Institutional Review Board [IRB], which meets monthly. IRB submissions are processed in parallel with those to the IMB and so cause no additional delays.

 
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