July 2018: Portugal Regulatory Update

CEICs meetings may only occur when the majority of its members are present. If a quorum is not reached at the 1st call for the meeting, a new one must be called and then a quorum is constituted as long as one third of the voting members are present.

Deliberations are taken with the qualified majority of two thirds of the present members. The decisions are conveyed to the sponsor, to the competent authority and to the sites ethics committees involved in the clinical trial concerned.

The internal regulations of the ethics committee and the law ask for a permanent declaration for the conflict of interests. At the beginning of each meeting every member must declare any conflict of interests on any topic of the scheduled programme. When this happens that member can not be present during the discussions related with that matter and can’t vote.

CEIC is supported from a secretariat of about 5 persons, two of them, pharmacists, who makes all procedural managements of clinical trials processes. There is also a system of quality assurance and internal standard operational procedures (SOPs).

CEIC issues guidelines on the ethical review of a clinical trial for an investigational medicinal product, or other ethical topics, and for that CEIC migh have subcommittees or working groups dedicated to special issues. These guidelines, have to be approved in the plenarium meetings before made public.

The National Ethics Committee for Clinical Research and his secretariat are funded by the Competent Authority (INFARMED I.P.). No fee is directly charged by CEIC and INFARMED I.P. charge sponsors according to a scale of fees.

All Clinical trials assessments have a CEIC number. At CEIC website the sponsor can at any moment consult the evaluation process (by CEIC or Eudra-CT number) since its validation until a decision is taken. After each meeting CEIC´s website is updated with the status of the evaluation of each clinical trial or amendment.

In urgent matters, the president of the research ethics committee may take a decision. For example, in a safety urgent substantial amendment the president may authorize or decline it. His decision should then be ratified by the plenary of the committee.

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