Quality & Compliance — Céline Hummer
Setting the Course for the Future
After a year marked by intensive dialogue with regulatory authorities, significant regulatory developments, successful training initiatives, the qualification of a new Phase I centre, and a comprehensive rebranding, the QA & Compliance department at the Swiss Cancer Institute takes a look back.
Dialogue with regulatory authorities
Several exchanges with regulatory authorities, during which current topics and processes were discussed constructively, took place in 2025. Particularly noteworthy was the solution-oriented collaboration with Swissmedic, which resulted in safety-related updates to the summary of product characteristics being published in a standardised format since the end of 2025. This constitutes a significant step forward for academic clinical trials involving authorised investigational medicinal products. Furthermore, the Swiss Cancer Institute was invited by the Federal Office of Public Health to nominate a representative to the expert committee responsible for revising the Human Research Act. This provided an important opportunity to contribute practical perspectives and scientific expertise directly to the legislative revision.
Implementation of the ICH E6 (R3) Good Clinical Practice (GCP) Guideline
The revised international ICH E6 (R3) Good Clinical Practice (GCP) Guideline entered into force in Switzerland on 15 August 2025. It reflects the increasing complexity of modern study designs, the use of new technologies and the growing volume of digital study data. The Swiss Cancer Institute assessed these changes through a comprehensive gap analysis and derived and successfully implemented concrete measures. This ensures that clinical research at the Swiss Cancer Institute continues to meet the highest international standards.
GCP Refresher Courses
The GCP refresher courses offered by the Swiss Cancer Institute and recognised by swissethics were adapted to the new GCP guideline. Demand exceeded all expectations: Over 600 physicians and study coordinators successfully completed the training. The high number of participants and the positive feedback underline the importance of this programme for the research landscape.
Phase I Centre Qualification
The oncology team at Kantonsspital Freiburg HFR (Fribourg Hospital), led by Prof. Dr. med. Alessandra Curioni-Fontecedro and Dr. med. Adrienne Bettini, was qualified as a new Phase I centre in 2025. The audit process was successfully completed, and the Swiss Cancer Institute looks forward to future collaboration with HFR in the Phase I field.
Rebranding
2025 was also marked by the organisation’s rebranding. The amendment of the Articles of Association, the update of the Commercial Register entry and the securing of trademark protection represent important milestones. These measures create a solid foundation for the Swiss Cancer Institute’s national and international visibility and legal protection.
Quality & Compliance: Céline Hummer, Chief Quality & Compliance Offcer