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Presented

Focused

OMCL Combating nitrosamines

After medicinal products contaminated with nitrosamines had to be recalled just under two years ago, Swissmedic’s own laboratory – the Official Medicines Control Laboratory, or OMCL – developed its own, more sensitive test for detecting contamination. Below we take a closer look at several cases.

Focused

Real-world examples Results and data

Massimiliano Conti (Head of Swissmedic’s laboratory) explains Switzerland’s role in the international effort to combat nitrosamines.

Examined

Authorisation Prevention rather than cure

Claus Bolte is Head of Swissmedic's Authorisation Division. Below he explains the difference between authorising vaccines and authorising medicinal products, describes the complex manufacturing process for vaccines and explains the situation as regards security of supply in Switzerland.

Examined

Covid-19 Research, testing and manufacturing

The coronavirus is currently holding the whole world to ransom. Ingo Matthes is head of the Authorisation sector's Quality Review division. He and his team answer enquiries and are responsible for reviewing the quality-related aspects of applications for variations and new authorisations of vaccines and medicinal products. Since the coronavirus outbreak, he has also been a member of Swissmedic's COVID-19 medicinal products task force. Here he explains the technical requirements associated with vaccine production.

Examined

Medical Devices The manufacturer withdrew the product worldwide.

As a scientific assistant in the Medical Devices Vigilance unit, Michaela Bürge investigates serious incidents involving medical devices. One was this case involving a US-based manufacturer.

Accompanied

Market surveillance Thumbs up or thumbs down

Officially, Ruth Mosimann is Head of Market Monitoring of Illegal Medicinal Products. She and her seven-person team form the national point of contact for issues involving illegal therapeutic products and work together with their cantonal counterparts, fedpol and other Swiss authorities. The specialists in her team decide whether or not medicines can be imported into Switzerland. We followed the expert as she went about her duties.

Highlighted

Facts & Figures

Permitted

Legal Affairs Valais pharmaceutical company falsified expiry dates on cancer medicine

Between 2007 and 2011, Alkopharma distributed a cancer medicine that had already passed its expiry date. The Martigny-based company tried to conceal the fact by relabelling packs. This created an issue because the medicine’s efficacy was reduced and it was also used in children. The courts imposed a relatively mild sentence on the grounds that there had been no specific danger to health. A review of the case from Swissmedic's perspective.

Globalised

Management Services Cooperation at all levels

Whether it’s the ICH, ACCESS or PIC/S, Swissmedic has attached great importance to efficient, networked and global cooperation with its international partner organisations ever since it was founded in 2002.

Probed

Human Resources + Finance Spreading knowledge

Swissmedic has launched an initiative to improve knowledge management by setting up a Community of Practice (CoP).

Probed

Digitalisation We intend to increase internal efficiency and effectiveness.

Urs Bühler is Deputy Head of the Infrastructure Division. He discusses the significance and potential of the digital transformation that is taking place within Swissmedic, and the associated opportunities and challenges.