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Presented

Swissmedic 4.0 Embarking on the digital journey

With its digital initiative Swissmedic 4.0, Switzerland’s therapeutic products agency has created a framework for exploiting the constantly changing requirements of the digital age as opportunities – an experimentation space for change and innovation in the years to come. The digital transformers Alexander Horst and Dominic Michel tell all.

Focused

Minergie/sustainability “Certified green”: Swissmedic's building strategy

Swissmedic is committed to an ecological and resource-efficient approach to infrastructure management. Since 2019, all Swissmedic properties have been certified with the MINERGIE® quality label. This standard ensures enhanced conservation of the building’s fabric and lower energy costs. Marco Osswald, Facility Management specialist, explains the specific challenges associated with the certification of protected historic buildings, the sustainability strategy and the reasons for making even greater use of renewable energy in future.

Examined

Combination products It all comes down to the right mixture.

Combination products are becoming increasingly important both for Swissmedic and for patients and users – but at the same time their handling is becoming ever more complex. This trend is attributable to a current harmonisation of the Swiss legal framework with the stricter European requirements for medical devices. The two specialists at Swissmedic, Bernhard Spörri and Sebastian Fuchs, discuss the various issues concerning combination products with reference to actual examples, the new regulations and the tasks of Swissmedic.

Accompanied

The work of the VMEC Animals and humans in the spotlight

The VMEC (Veterinary Medicines Expert Committee) is the counterpart to the HMEC (Human Medicines Expert Committee). Chair Barbara Knutti talks about her vocation for veterinary medicine, the variety of the job and the greatest challenges faced by the committee. We visited her at her home in the village of Corcelles in the canton of Vaud.

Highlighted

Facts & Figures

Highlighted

Interview mit Swissmedic-Direktor Raimund Bruhin

Interview with Raimund Bruhin, Executive Director of Swissmedic

Das Schweizerische Heilmittelinstitut Swissmedic ist eine selbstständige Organisationseinheit des Bundes und erfüllt ihren gesetzlichen Auftrag unabhängig. Swissmedic soll Aufsichts- und Regulierungsentscheide mit Distanz zum politischen Tagesgeschäft fällen. Wie steht es um diese Autonomie gegenüber der Politik und anderen Stakeholdern während der Covid-19-Pandemie? Kann Swissmedic ihre Aufgaben ohne inhaltlichen Druck erfüllen und Entscheide basierend auf rein wissenschaftlichen Grundlagen treffen?

Interview mit dem Swissmedic-Direktor Raimund Bruhin

Globalised

Focus on safety Clinical trials and inspections

Swissmedic reviews and approves clinical trials before they start and subsequently monitors the conduct and management of these research projects. Visible tracked down and contacted Alexander Mion, Head of the Clinical Trials Department (CT), who drew back the curtain and, together with his colleagues Verena Gafner and Simone Ferbitz, introduced us to the world of clinical trials.

Probed

Drug safety Finding out about pharmacovigilance

Pharmacovigilance covers all activities concerned with the identification and prevention of adverse drug reactions (ADRs). Any serious or previously unknown adverse reactions that occur must be reported as soon as possible. As a result, previously unknown drug risks can be identified and addressed with appropriate measures. How the reporting system works in Switzerland, why it needs the international sharing of information and how to deal with reports relating to corona vaccination, is all explained by Dr. Christoph Küng, Head of the Safety of Medicines division.