Regulation

Last Updated on Thursday, 23 April 2009 13:07 Written by Administrator Thursday, 05 February 2009 15:30

Goals and intended implementation of requirements in regulatory toxicology to support the authorities

The principle aims are:

• To provide information asked for by the regulatory Authorities in a timely fashion and of a high scientific quality. Questions asked by the authorities can span the whole range of applied human toxicology.
• To support Authorities (Federal, Cantonal) or customers from the private sector to establish documents, protocols and documentations in the toxicology domain.
• To perform, on a fee for service base, additional applied and targeted human toxicology research.
• To perform, on a fee for service base, specialized sample testing.
• To be an information resource for the State & Cantonal Authorities, the Media or any relevant public or private Institution.

Implementation
All the questions and requests coming from the Authorities or the Industry will be handled by the CEO and his staff, who are also going to perform all the correspondence needed. In other words, the two staff toxicologists/regulatory affairs specialists, both members of the regulatory unit, should have the capacity to respond to most enquiries. More complex and specialized requests will be dispatched to the best participating group leaders in the field. A good collaboration with existing service institutions, in particular with the Swiss Toxicological Information Centre (STIZ), will be established. Questions from the public regarding toxicity associated with chemical substances or other products will be transferred in mutual agreement to the STIZ. The CEO is responsible that answers are provided quickly and with a scientific content of high quality. Regular meetings of the executive committee (see below) and of the extended group leader committee (see below), including selected toxicologists from the federal government, will ensure that the CEO, the two toxicologists/regulatory affairs specialists and the group leaders meet the expectation of the Authorities, the Industry or any public or private clients.

Samples to be analyzed will be sent to the most adequate participating laboratory. On request, newly financed regulatory and/or research mandates will be dispatched by the executive committee to suitable research groups of the centre. As stated above, the participation of the Geneva Department of Laboratory Medicine & Genetics with four services within the department (Clinical Pathology, Dermatology, Genetics and Laboratory Medicine), the Departments of Clinical Chemistry and Clinical Pharmacology & Toxicology of the University Hospital of Basel, the Institute for Work & Health of the Western Switzerland University Centre of Legal Medicine, the Swiss Centre for “Terato-vigilance” and the other institutions included in the Centre ensure strong logistic setup for performing these services.

In addition, one of the main applicants, Prof. Stephan Krähenbühl, and one of the co-applicants, Prof. Pierre Dayer, are the head and a member of the Medical Experts Committee of Swissmedic, respectively, and are therefore well aware of most regulatory problems of the Swiss authorities, at least concerning drugs. They will be long term members of the strategic board and/or the Executive board and therefore leading these relevant aspects in the regulatory unit of the Centre.

The Federal Authorities, the Industry and the Swiss Society of Toxicology will select representative members for the Strategic board and will therefore participate to all strategic decisions ensuring adequate use of the resources and that expectation are met.

Other activities
Symposia & Meetings will be organized to disseminate & stimulate new knowledge and will be open to all interested parties. Regular meetings will be organized between the regulatory authorities and representatives of the Centre (CEO, staff of the CEO and teaching, scientific and service group leaders) to maximize communication. Bi-monthly morbidity & mortality toxicology conference (BM3TC) will be organized to develop problem oriented continuous education learning. A SCAHT web server will be established.

Continuous applied human toxicology education modules will be offered to the public and the private sector. They should meet the European requirements to obtain the title of European toxicologist (see also section 5).

* The elaboration of the job advertisement as well as the selection procedure will be undertaken by a provisional strategic board composed of a representative of the Task Force Confederation (Federal State representative), the Swiss centre for applied eco toxicology, the Swiss Society of Toxicology, the participating universities, level of rector or vice-rector for research or alike, a representative of the industry and the two main applicants.