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ICH adopts E6(R3) guideline on good clinical practices

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

13.03.2019

AMBV Chapter 5 regulates the temporary authorisation for the use of medicinal products in accordance with Art. 9b Para. 1 TPA. The procedures formerly known as "compassionate use" (now temporary authorisation) refer to therapeutic products whose efficacy has already been proven in clinical trials.

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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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Publication of guiding principles for registries in human research

19.02.2019

Which data collections in human research are subject to authorisation by an ethics committee and when is the consent of the participants or their information on the right to dissent required?

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