Responsibilities
Under the terms of article 19 of the EU Directive 2001/20/EC, sponsors not established in the EU are required to submit trials through a legal representative in the EU. There are many obligations for sponsors including reporting to ECs and CAs and adverse event recording and reporting.
I.D.E.A. Ltd. is able to fulfil all these requirements in a speedy and effective manner. I.D.E.A. Ltd. can perform this recording, coding and reporting combined with expert medical review.
The Sponsor Representative service
Article 3 of the EU Directive states that the sponsor should have a liability insurance for the performance of studies in Europe. I.D.E.A. Ltd. can offer multiple insurance companies that have been preselected because of their conditions and experience in the area of liability, product insurance, and volunteer/ patient insurance.
The EU Directive demands the production of an Investigational
Medicinal Product Dossier (IMPD).
I.D.E.A. Ltd. can help the sponsor to accomplish and fulfil these needs by collating all necessary information and compiling
the IMPD.
In addition, the Sponsor Representative service of I.D.E.A. Ltd. is able to terminate or indicate the premature termination of a trial in case any central authority or ethics committee suggests such measure.
The Competent Authorities
The Competent Authorities are to perform random audits to assure compliance with the standards of GMP and GCP. I.D.E.A. Ltd. has staff to guide those audits that may be performed within the European Union or at the sponsor’s site, if necessary. The staff of I.D.E.A. Ltd. will accompany the sponsor during all this process until the audit has been completed.
For the import of the medication to the European Union, a Qualified Person must take responsibility that this medication has been produced according to GMP conditions. I.D.E.A. Ltd. can provide Qualified Person/Persons and can provide analytical services and facilities to perform any further analyses of the product that may be necessary.