Agence Franaise de Scurit Sanitaire des Produits de Sant Afssaps

The inspection is defined in the ICH good clinical practice text as:

"The act by a regulatory authority(ies) of conducting an official review of documents, facilities, records, and any other resources that are deemed by regulatory authority(ies) to be related to the clinical trial and that may be located at the site of the trial, at the sponsor and/or contract research organisation's (CRO's) facilities, or at other establishments deemed appropriate by the regulatory authority(ies)."

This part of the chapter is based on a presentation made by PierreHenry Berthoye, head of preclinical/clinical inspection of Afssaps and documents provided to the authors by him.13'14

The French agency has inspectors (physicians or pharmacists) among its members. They are in charge of compliance by industry, contract research organisations, or any type of sponsors, with the French legal requirements concerning human health products (medicinal products, medical devices, blood derivatives, etc.). French public health inspectors and Afssaps inspectors must ensure compliance with regulatory texts. In the case of scientific misconduct by a physician, the Conseil Régional de l'Ordre des Médecins (Regional Medical Council) can be involved.

The French inspection system of clinical data is national and independent but closely linked to the EMEA inspection unit. The latter coordinates national inspections only for European reasons or in terms of harmonisation of procedures and tools. As each Agency of the European member states, the European Agency for the Evaluation of Medicine (EMEA) has to ensure:

• the protection of persons involved in clinical trials;

• that clinical data collected in order to evaluate the efficacy/efficiency and safety of medicinal products are reliable and of good quality.

At Afssaps, mission statements are given to the non-clinical/clinical inspection department by the Direction de l'Inspection des Essais, either on its own or at the request of the Evaluation Direction of Afssaps, or of EMEA for European procedures of Applications for Marketing Authorisations.

At any time during the life of a medicinal product, the selection of a clinical study is decided by the following criteria:

• at random according to the type of studies (phases, size, regulatory, or epidemiological importance);

• for a specific reason or cause, including one or more of the following items:

• characteristics of the product and sponsor

• type of study and study population most member states for the sponsor, the investigator, and even health authorities.

• Criminal procedures

Criminal law sets penalties for fraud, and complaint by the sponsor or the health authorities leads to the initiation of an investigation, which can include the participation of outside experts. In France, in the case of proved fraud, a physician working in the public hospital sector generally incurs more severe sanctions (fines and/or imprisonment) than would be applied to non-hospital personnel.

Fraud by the sponsor

Still harder to detect than fraud by investigators is fraud committed by a manufacturer. This may lead to the invalidation of all or part of a registration file following inspection by the health authorities.

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