Focus

In vitro diagnostic (IVD) medical devices - Clinical performance studies: Expected changes in the legal requirements and BASEC

Publications swissethics

Annual reports and other publications of swissethics

Updated documents

List of documents recently updated by swissethics

News

Updated Guidance for providers of courses on Research Ethics and GCP: new including GCP Refresher courses

06.08.2019

Since 1 January 2014, GCP course providers can have their GCP courses for investigators and sponsor-investigators in Switzerland recognised by swissethics.

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Position paper of swissethics on how to manage incidental findings in medical research

06.08.2019

Im Rahmen der Humanforschung gibt es durch Diagnostik und Untersuchungen in einem nicht unerheblichen Prozentsatz im Rahmen von klinischen Studien und Projekten Zufallsbefunde.

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Important remarks on the information on the "Temporary authorisation to use medicinal products in accordance with Article 9b paragraph 1 HMG" of 13.3.2019

10.04.2019

The information published by swissethics on 13.3.2019 is aimed at pharmaceutical companies, i.e. sponsors who can apply for a temporary authorisation for their drug under certain conditions.

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Temporary authorisation to use medicinal products in accordance with Article 9b para. 1 TPA

13.03.2019

The total revision of the Ordinance on the Authorisation of Medicinal Products (AMBV) entered into force on 1st January 2019.

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Publication of version 2 of the national General Consent

22.02.2019

With the General Consent (GC), persons treated in hospital can consent to the further use of their personal data and samples for research projects. unimedsuisse, together with swissethics, publishes today the version 2 of the national GC.

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